Tecfidera FDA Approval Announced Today - 3/27

[lawnerd]

What say ye? I came here hoping to learn all about this new drug. Surprisingly, I find I am the 1st to make note of its FDA approval today.

I haven't been able to continue with injections since last September because of multiple site reactions to B -Still have 4 locations which are not fully healed.

I have neuro appt in early May. I think I hope neuro will believe one of the orals will work for me. I say "I think" because I have been tons healthier since I quit taking the B. In past few years, I could rarely manage to go a month without needing to go to my GP with some bug or another -- mainly respiratory.

Fortunately, I haven't had any MS exacerbations or relapses, etc. in probably 7 or 8 years.

Since I quit the B, I have only been to GP once and that was because I needed to get refill prescriptions for my non-MS meds. In the past couple of weeks I caught "the cold" that is going around town. But only felt puny for about 36 hrs and nothing close to a need to see the doc.

I have found one article which estimates cost of Tecfidera at 50K to 60K/ year -- horrendous, but about what my insurance was paying for my B.

What wisdom does the group have to share about Tecfidera? About Tecfidera vs. the other orals?

Thanks to all in advance.
I hope the Easter Bunny is good to you!

[Virginia]

Lawnerd, I haven't had the chance to look into it much, but my Doctor is wanting me to take a look at it in September. I saw him last week and will see him again in September. I knew that it had been recently approved in Europe, but was not aware that it had been here. According to the paper I read it in the main side effect is gastro-intestinal problems. Not sure I can take it because it acts as an anti-inflammatory and I can't even take one Advil without getting really sick.

Would love to hear some live feedback from someone who is taking it.

[agate]

I'm not taking it but here are some excerpts from an article in the New York Times (March 28):

3rd Oral Drug to Treat MS Is Approved by the F.D.A.

By ANDREW POLLACK
A chemical once used to treat sofas — until it was found to cause rashes and blisters in people who sat on them — is now poised to become a major therapy for multiple sclerosis.

The Food and Drug Administration on Wednesday approved the chemical, dimethyl fumarate, which will be sold by Biogen Idec under the name Tecfidera, the third of a spate of oral drugs that are transforming the treatment of multiple sclerosis.

Despite the drug’s seemingly odd history, Wall Street analysts, doctors and patients expect Tecfidera to become a blockbuster because of its combination of efficacy and relative safety and the convenience of being a pill. Doctors and analysts say some patients have been putting off starting treatment until Tecfidera is available.

Feedback from doctors was “highly positive, with a strong consensus that Tecfidera offers a more favorable clinical profile than other oral or injectable first-line options,” Thomas Wei, an analyst at Jefferies, wrote on Monday.

...

While self-injected medicines like Avonex from Biogen and Copaxone from Teva that entered the market in the 1990s are still used by the majority of treated patients, newer oral drugs are making inroads. In addition to Tecfidera, the other two oral drugs are Gilenya from Novartis, approved in 2010, and Aubagio from Sanofi, approved in September.

The approvals will solidify Biogen’s position as a leader in multiple sclerosis drugs. In addition to Tecfidera and Avonex, the company also sells Tysabri, a highly effective intravenous drug but one that can cause a potentially fatal brain infection.

Biogen shares have more than doubled in the last two years, largely because of anticipation about Tecfidera. The shares closed on Wednesday at $182.68, up about 3 percent.

Biogen, which is based in Weston, Mass., did not immediately announce the price of Tecfidera, which was known as BG-12 during its development.

Stock fund portfolio managers polled by the research firm the ISI Group on Wednesday predicted a price of about $51,000 a year, which would be roughly in line with prices of the injectable drugs, but less than the $60,000 a year list price of Gilenya.

The effectiveness of multiple sclerosis drugs is often judged by how much they reduce the frequency of relapses, which are severe flare-ups of symptoms, compared to a placebo in clinical trials.

The injectable drugs reduced the frequency about 30 percent, as did the new oral drug Aubagio. Gilenya cut the rate about 54 percent.

Tecfidera cut the relapse rate 44 percent in one trial and 53 percent in another, which might put it a bit behind Gilenya. Tecfidera is also taken twice a day, while Gilenya is taken only once daily.

But Gilenya has side effects that make it off limits for some patients and require careful testing and monitoring for heart, liver and eye problems. Patients are supposed to remain in a medical facility for at least six hours after taking their first dose to make sure their heart does not slow down too much.

Tecfidera will have fewer restrictions and testing requirements. The prescribing information does recommend that blood cell levels be tested before a patient starts on the drug and annually thereafter. That is because Tecfidera can reduce white blood cell levels, leaving patients potentially vulnerable to infections. And some studies in animals suggest that the drug might cause fetal harm, making it a questionable choice for pregnant women, the label says.

Tecfidera’s most common side effect is flushing, which occurs in about 40 percent of patients. The drug can also cause nausea and diarrhea.

Dimethyl fumarate and some closely related compounds are simple molecules that have been used as food additives. The compound was also used to protect upholstery and shoes from mold during storage. But people in Europe developed skin irritation and other problems, causing its use in consumer goods to be banned there.

The first use of it in medicine was in 1959, when a German chemist treated his own psoriasis. A drug called Fumaderm, which is similar to Tecfidera, was approved to treat psoriasis in Germany in 1994.

It is not quite clear how Tecfidera works. It is thought that one way is to activate a pathway known as Nrf2, which helps protect the body from oxidative stress.

... European regulators recommended last week that Tecfidera be approved as well.

Only registered and activated users can see links., Click Here To Register...

[renee]

Who prescribed this stuff to furniture?

[agate]

Who prescribed this stuff to furniture?

It didn't do well when it was used on furniture or shoes, and so they thought they'd use it on us. Maybe at least we won't get so moldy if we take it.

[agate]

More on this from the MSAA (March 28, 2013):

Tecfidera Approved for the Long-Term Treatment of MS

The United States Food and Drug Administration (FDA) announced on March 27, 2013 that it has approved Tecfidera™ (dimethyl fumarate or DMF, formerly known as BG-12) as a first-line therapy for the long-term treatment of relapsing forms of multiple sclerosis (MS). Tecfidera’s parent company, Biogen Idec, submitted a New Drug Application (NDA) to the FDA for the approval of this drug in February 2012. ...

Tecfidera is the 10th drug to be approved as a disease-modifying therapy (DMT) for the long-term treatment of MS. Tecfidera is administered in pill form orally (by mouth) and is the third oral DMT approved for MS. The approved dosage is 240 mg to be taken two-times daily. The previous oral medications were approved in 2010 (Gilenya®) and in 2012 (Aubagio®). Five other DMTs for MS are taken via self-injection – the first of which was approved in 1993; the remaining two DMTs are administered via intravenous injection. While none of these treatments can cure MS, they all have been shown to be effective in reducing the number and severity of relapses (disease flare-ups), slow disease activity (in terms of fewer and less-active lesions in the brain), and in some instances, slow disease progression.

MSAA Chief Medical Officer Dr. Jack Burks explains, "With the FDA approval of Tecfidera, a pill taken twice daily, another first-line oral treatment option for people with relapsing forms of MS becomes available. The combination of robust effectiveness data with only transient side effects consisting mainly of flushing and gastrointestinal symptoms adds another valuable treatment option for patients and doctors to discuss. The future for individuals with MS is brighter than ever, and this is true not only for those with relapsing forms of MS, but for others also. Encouraging drug trials are currently underway in an effort to provide treatment options for the entire MS community, including those with non-relapsing, progressive forms of the disease."

Mechanisms of Action – How Tecfidera Works

Tecfidera is related to a medication called Fumaderm®, which was previously shown to be effective in patients with psoriasis and used for this indication in Germany for many years. The mechanism of action in MS is still under investigation; however, Tecfidera may have a distinct dual mechanism of action.

First, it is an immunomodulator, modulating or affecting how the immune system functions. It exhibits anti-inflammatory properties, which is an important component in the effective treatment of relapsing forms of MS. This induces anti-inflammatory cytokines (small proteins that may stimulate or inhibit the function of other cells) and appears to suppress damaging macrophage cell activity. Macrophages are a type of white blood cell that can damage both the protective covering (myelin) to the nerves of the central nervous system (those of the brain, spinal cord, and optic nerves) and can also damage the nerves themselves.

Second, Tecfidera may have neuroprotective effects, potentially protecting the nerves and their myelin covering from damage. This is due to its activation of a substance that is critical for resistance to cellular damage (from what is termed "oxidative stress"), and is also critical for normal immune function.

Completed Studies with Tecfidera

Two large Phase III trials were conducted with Tecfidera; both showed positive outcomes. The Phase III DEFINE study, which compared two doses of Tecfidera against placebo in 1,200 patients, was completed in February 2011. The Phase III CONFIRM study, which enrolled 1,232 patients, tested two dose levels against placebo, and also compared Copaxone against the same placebo group; the study was completed in September 2011.

The Phase III DEFINE study was a multicenter, double-blind trial of Tecfidera. In this study, 240 mg of Tecfidera was given either twice or three times daily versus placebo for two years. The study met its primary endpoint with a 49 to 50-percent reduction in the proportion of patients who relapsed during the study period. One of the secondary clinical endpoints was confirmed disability progression. Each of the two Tecfidera doses reduced the risk of sustained disability progression (for at least 12 weeks) by 34 to 38 percent.

The Phase III CONFIRM study was also a multicenter, double-blind trial. For two years, it compared the same two doses of Tecfidera with placebo (as done in the DEFINE study) and also compared the same placebo group to a group receiving daily subcutaneous injections of Copaxone. (Please note that the study was not designed to compare the effectiveness of Tecfidera to Copaxone.) The study met its primary endpoint with a reduction in relapse rates of 44 to 51 percent for Tecfidera compared to placebo. No statistically significant difference was observed in the remaining clinical endpoint of confirmed disability progression, possibly due to the unexpectedly low rate of progression in the placebo group.


In both studies, compared to placebo, individuals given Tecfidera had significantly reduced disease activity as shown on magnetic resonance imaging (MRI) scans. These included significant reductions in the number and size of new and enhancing brain lesions (areas of disease activity, inflammation, and potential damage to the myelin and nerves).

Continuation Studies

A continuation study of 1,736 patients who participated in the DEFINE and CONFIRM studies called ENDORSE is evaluating the long-term safety profile of Tecfidera as well as its long-term efficacy on clinical outcomes, MRI scans, and quality-of-life. The study will continue through 2013, although initial data were presented in fall 2012. No new safety concerns were identified, and no deaths were thought to be related to the medication. There were 14 malignancies observed (less than 1 percent) in this patient population, though it was not apparent that these were directly caused by Tecfidera.

The Phase II EXPLORE trial is evaluating oral Tecfidera as a combination therapy with an injectable medication. It will determine the safety and tolerability of Tecfidera when administered in combination with interferons or Copaxone to 100 people (who continue to have evidence of disease activity despite receiving consistent treatment for at least one year). Efficacy endpoints (determining the effectiveness) will also be assessed in a subset of participants. The study concluded in 2012 and the results are expected in 2013.

Side Effects and Adverse Events

In the large studies leading up to the approval of Tecfidera, flushing and gastrointestinal events, such as diarrhea, nausea and vomiting, and abdominal pain, were the most commonly reported side effects. Flushing and gastrointestinal events occurred in approximately 30 to 40 percent of patients and occurred more often at the beginning of treatment, decreasing in frequency after the first one to two months on this medication.

Other adverse events, which were mild or moderate in severity, included upper respiratory infection, pruritus (chronic itching), and erythema (skin redness or rash). The only serious adverse events (aside from MS relapses) to occur in two or more patients taking Tecfidera during these large studies was gastroenteritis (an inflammation of the lining of the intestines) and gastritis (an inflammation of the stomach lining).

In terms of long-term health risks, reduced white-blood cell (lymphocyte) counts were seen during the first year of treatment (lymphocytes are disease-fighting cells). However, the incidence of infection did not differ between the treated and placebo groups during the studies. Because of the reduced white-blood cell counts, the FDA recommends that prior to starting Tecfidera, and annually thereafter while still on the treatment, patients be given a complete blood count to monitor their ability to fight infection.

The occurrence of malignancies were low and did not differ between treatment groups in the DEFINE trial. No malignancies were reported with the CONFIRM trial.

During the first six months of therapy in the DEFINE study, liver enzymes were elevated in 6 percent of individuals taking Tecfidera, compared to 3 percent of the placebo group. No cases of liver failure were reported in either study. Excess protein in the urine (proteinuria) was observed slightly more often in the treated groups versus the placebo group of the DEFINE study. No cases of kidney failure were reported in either study.

For More Information

Additional information on Tecfidera may be found by visiting Only registered and activated users can see links., Click Here To Register.... Individuals may also learn more through Biogen Idec’s patient assistance program’s website at Only registered and activated users can see links., Click Here To Register... or by calling (800) 456-2255. In addition to MSAA’s website (at Only registered and activated users can see links., Click Here To Register...), individuals may call MSAA at (800) 532-7667 for more information about MS and its treatments. Questions to MSAA’s Client Services Department may be emailed to MSquestions@mymsaa.org.

_________________________________

Written by Susan Courtney
Reviewed by Jack Burks, MD

[Lazarus]

Hello everyone

I am JVC positive which makes the rituxan I do more dangerous so my neuro has been eager for approval of GB 12.
He says it has a good safety record and that he thinks it would be helpful for me.

I am doing another round of rituxan next week so I won't think about switching for another 6 months. I'll be able to read how everyone else who starts now does on it.

[SalpalSally]

Who prescribed this stuff to furniture?

I read that China used it on Furniture, to prevent mold growth, and that
it had to be recalled, because it caused rashes and other allergic reactions
in people. I'd be interested in how it made the transition to something that
is safe for people to chew on???

[Lazarus]

Information on the cost of tecfidera....Obviously, I will not be paying out of pocket

I am lucky I have a policy in addition to Medicare. but I am very new to medicare and am not sure how it all connects. So far, my drugs are all covered!

This is the article:
The highly anticipated number is in: Biogen Idec's ($BIIB) newly approved Tecfidera has a ********* price of $54,900 per year, the biotech giant revealed on Friday. With the U.S. market debut of the oral multiple sclerosis drug set for Monday, Biogen plans to hit the market for MS pills with a lower price than Novartis' ($NVS) Gilenya, which is arguably the company's top competition.

The Tecfidera price falls on the high end of the $50,000 to $55,000 range predicted by RBC Capital Markets analyst Michael Yee. Existing MS pills on the U.S. market include Gilenya at $58,000 per year and Sanofi's ($SNY) Aubagio for $45,000, according to the analyst's numbers. So Biogen has set a middle-of-the-field price for a pill that many analysts expect to become the top therapy in the oral MS class.

"We think this price represents a solid value to the MS community and demonstrates our commitment to ensuring patient access," Biogen spokeswoman Monique da Silva told FiercePharma in an email. Re


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Biogen has been a leading player in the MS market for years with top-selling injected therapy Avonex and the IV drug Tysabri, yet the company's sales organization needs to master a whole new pitch for Tecfidera with many physicians who are unfamiliar with the product. Naturally, docs will want to know how the MS pill stacks up with rival therapies. On the safety score, Tecfidera comes with a relatively clear profile compared with Aubagio, which is saddled with a black-box warning about increased risk of liver problems, and Gilenya, which regulators warn should not be used in patients with heart disease.

However, Gilenya has reduced relapse rates in MS patients in studies by about 54% compared with 44% to 53% in those studied on Biogen's pill and 30% in patients taking Aubagio in clinical trials, The New York Times reported. Yet analysts expect Tecfidera to ultimately garner the most sales. EvaluatePharma pegs the consensus estimate on peak sales of Tecfidera at $3.8 billion, more than most analysts expect Gilenya and Aubagio to bring in for their pharma providers.

Related Articles:
Biogen's Tecfidera expected to hit the MS market running
Biogen Idec snags blockbuster approval for oral MS drug
Biogen Idec rolls up FDA OK for blockbuster multiple sclerosis drug Tecfidera






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[lawnerd]

Many thanks to all of you who have provided so much information about Tecfidera. WOW! I have more to think about that I thought concerning treatment.

I haven't been here in months. As the date for a consult with a MS center neuro approaches at the end of June, I am again trying to focus on treatment issues and decisions. Since I saw the more recent post which deals with Techfidera, I decided to reply to this post instead to bring it forward.

To update on my situation,
All but one relatively small B injection site reaction was healed by early April. I was scheduled to have scar revision surgery on the worst of my reaction sites [2009] in mid-May. Then, out of the blue, a site on my right buttox came back to life, scabed up then scab came off. I went to my early May neuro appointment [on a Friday] with cellulitis asking for an antibiotic. He referred me to the local wound center. Neuro said he feels my situation is now too complex for anyone but an MS specialist neuro to make treatment decisions for me and has referred me to nearest MS Center.

When I hadn't heard from the wound center by the next Tuesday [haven't heard from wound center to date], I knew I needed to be seen by a doc that week. Got in to see my GP that Thurs afternoon. GP sent me straight to surgeon. Surgeon hospitalized me the next day for IV antibotics and an ultrasound to see if I had any encapsulated infection. And, if such infection, surgery. No encapsulated infection. Had the IV antibiotics. Followed by 7 day course of double strength Bactrim.

At end of Bactrim, I had follow up with the surgeon. He said despite resolution of infection, I had so much necrotic tissue that I had to have surgical debridement. Fri before last I had that done out-ptnt. I now have a hole about the size of 1/2 of a pingpong ball in my rear end. [My BMI is 17 so you can imagine how little rear end I have to begin with.] Surprisingly [to everyone, I think], I have had virtually no pain from the surgery. I am not sure if that is ultimately good or bad.

1st post surgery appt with surgeon, last Thursday. He said not healing as expected and instructed me to increase re-packing and dressing the site form 1x/ day to twice a day. [Qiute a trick to pack and dress one's own wound in this location!] Told to return in 3 wks.

I didn't think things looked right this week so I returned to doc today [my surgeon on vacation, saw a partner who also works in wound center]. Wound center doc/surgeon said I was right to return, that healing was stalled by increasing slough. He said ,as hard as it was to believe, he wonders if the B is through doing its damage. He prescribed dressing wound with Collagenase 1x/day and told me to quit packing wound as that may be supressing blood flow. He also said if things have not improved greatly within next 2 wks that I will need surgery again! I have a brain MRI scheduled for next week, see my surgeon again in 2 weeks and go to the MS Center neuro the week after that . . .

With that report, I again say thanks to all who have provided information about the new oral drug.

I am learning way, way too much information about chronic wounds! I do value the wisdom of this group. If anyone has insight to share regarding trying to heal my Betaseron chronic wound, I will appreciate your sharing and thank you in advance for doing so.

All this from a Betaseron shot I gave myself sometime late last summer!!

[agate]

Thanks for the update, lawnerd. You've been going through quite an ordeal.

No doubt about it--any shot can cause major problems. (When I was a kid I had to have surgery to remove abscesses caused by a penicillin shot.)

Let's hope you're on the mend at last. Will you want to wait a bit before starting on any new MS drug, just to keep everything as simple as possible until you're completely healed up?

No pain does sound good, but there can be numbness and that's not so good.

Good luck with the neuro consult!

[Lazarus]

Ouch, Lawnerd.

In 1998 I had a reaction to Betaseron shot. had a strange hard red space on my stomach. the surgeon said. It was a spider bite and put in a needle to drain it even though he said it had no fluid....mistake! It became worse, turned gangrenous and put me in the hospital on IV antibiotics for 2 weeks. That is what led to my retirement from teaching.

It sounds like you have been very aware (even though several doctors were not!). Whew, you have had a time of it. I know that word slough from when my husband was ill last summer. Not good.

I will think of you. I especially want to see what you decide. I will be facing the same situation at the beginning of July when I see my neurologist.

[agent107]

furniture cleaner/ms land

hello all,

i see my neuro in early july and know he is crazy mad about discussing new drugs so i'm glad to hear/see these posts -- am JC positive, have been on tysabri since it's inception --

so am glad for the info on the derivation of these oral drugs -- [when i was diagnosed and prescribed with avonex i found it was derived from the cells of chinese hamsters . . . . ]

what can i say -- i'm loathe to change meds. -- i'm inclined to wait it out to see what side effects will or will not emerge -- am not in guinea pig mode

i'll bring a bottle of stain cleaner with me to my neuro appt.

agent107

[Jeanie Z]

:) Hi everyone. I had a friend with a terrible open oozing bedsore. I had her put pure 100% honey on sterile gauze and apply it several times a day. Within days it was not as red and a lot less oozing and about a week later was gone. Her visiting nurse did not approve of it but was pleased when it worked.

When you have tried everything else and no improvement you might want to try this. Jeanie :)