FDA Changes Course for Elan and Biogen Idec

A little less than four years ago, Elan (NYSE: ELN  ) and partner Biogen Idec (Nasdaq: BIIB  ) received approval to market their innovative multiple sclerosis treatment Tysabri. Three months later, in February 2005, the drugmakers "voluntarily" withdrew Tysabri from the market because of two occurrences of a rare and frequently deadly brain disorder in patients taking the drug.

Tysabri eventually returned to the market in the middle of 2006 with a plan in place to minimize risk. Flash-forward to a couple of weeks ago, and Elan and Biogen Idec reported two more occurrences of the rare brain disorder, called progressive multifocal leukoencephalopathy (PML), in patients taking Tysabri.

On Monday, the Food and Drug Administration posted an alert on its website (seen here) to health-care professionals in response to the new cases of PML and put to rest any worries that Tysabri would be pulled from the market again. The FDA also said it was working to "amend the product labeling" for Tysabri to account for the new cases of PML.

When the two cases of PML were diagnosed in Tysabri patients in 2005, it was in patients taking the drug in combination with Biogen Idec's other multiple sclerosis treatment, Avonex. A third case of PML associated with Tysabri was discovered later as well. The FDA, Biogen Idec, and Elan then took action to help restrict Tysabri from being used with other drugs that affect the immune system, like Avonex, Rebif from Pfizer (NYSE: PFE  ) , or Remicade from Johnson & Johnson (NYSE: JNJ  ) . Tysabri was brought back onto the market.

But the two new cases of PML that arose last month were in multiple sclerosis patients who were not taking any other drugs with Tysabri. With this new development, the worry was that the FDA might take drastic further steps to restrict Tysabri's use or take it off the market again, as it did in 2005.

Tysabri's label already indicates that it's recommended for use in patients failing with other commonly used multiple sclerosis therapies like Teva's (Nasdaq: TEVA  ) Copaxone or Bayer's Betaseron. Undoubtedly, there won't be as much demand for Tysabri with these two new safety issues, and it's now even more unlikely that Biogen Idec will hit its target of "100,000 patients"  taking Tysabri by the end of 2010. But investors can now rest a little easier knowing that the FDA isn't handling the new adverse events with Tysabri the same way that it did in 2005.

Pfizer and Johnson & Johnson are Motley Fool Income Investor selections. Pfizer is an Inside Value pick, too. Biogen Idec is a Stock Advisor recommendation. Try any of our Foolish newsletters today, free for 30 days

Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has an A+ disclosure policy.


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  • Report this Comment On August 26, 2008, at 4:20 PM, pat1966 wrote:

    Brian,

    Get the facts straight b4 writing this kind of stuff - Tysabri was voluntarily withdrawn by Biogen, in agreement by FDA.

    The 'issues' you refer to are hardly new, although the treatment of PML in these cases has now been shown to be at least treatable.

    The patients on therapy with Tysabri WILL NOT give it up, or stop using it, as they have no other drugs to go back to, they've failed all the 'regulars' . A large % of these patients have finally received part of their lives hack, and are improving. This is 'disease modifying' at its best, with extremely low risk. Finally!

    If anything, Tysabri has now been shown to be the most effective MS drug out there. Unlikely to make targets? Hardly

  • Report this Comment On August 26, 2008, at 4:30 PM, chmod000 wrote:

    Good that the FDA is being reasonably level-headed on this one as T has many benefits.

    There are also a # of unconfirmed PML cases reported to the FDA through its medwatch program.

    Those cases have also been discussed in the popular press and can be seen here:

    http://www.getezurl.com/?i8uOQ0tNdf

  • Report this Comment On August 26, 2008, at 10:33 PM, XMFBreakerTinker wrote:

    <<<Undoubtedly, there won't be as much demand for Tysabri with these two new safety issues, and it's now even more unlikely that Biogen Idec will hit its target of "100,000 patients" taking Tysabri by the end of 2010.>>>

    Bryan,

    Have you kept up with the latest news on the treatment of these two PML patients. One has made what is called a "full recovery" and the other is stated to be starting his recovery. Neither is permanently neurologically damaged (the sicker patient does have some issues, but that patient, if you read his history had some very serious issues that caused him to take tysabri to begin with, but is largely recovering from the effects from the PML and the other patient has made nearly a full recovery) and neither patient is dead. In fact the less sick patient is called "out of the woods". Yet PML was suppose to be an untreatable death sentence, with the rare exception where it only leaves you a mental vegetable.

    Now you say that "undoubtedly" there won't be as much demand, yet the risk profile for tysabri is potentially changing to one of possible death to manageable. I must differ. In fact another 1 ot 2 PML cases, if treated in the same fashion, with the same result, will probably increase tysabri sales as the risk profile changes to the better. Patients and neurologists will stop thinking of death, and instead think just of the incredible efficacy tysabri brings relative to all other drugs on the marketplace. This does not even consider the increased competitive profile of the drug compared to those MS drugs coming up in the pipeline that are full of their own side effects, which may not be so manageable as tysabri induced PML is at least gaining the perception of being.

    Could be an utter fluke these two PML patients. The sicker one still has issues that we will need to follow. The less sick one could perhaps relapse. But as of now the less sick one has apparently made a complete recovery and his doctor is not expecting further PML issues for this patient.

    Just a though that you may want to reassess this comment in light of these developments. The problem with tysabri is that PML is so rare that it does not enable great precision in risk forecasting, nor enable great numbers of patients to be treated to test treatment protocols. Then again, tysabri PML is rare, and apparently manageable if caught early.

    Would appreciate any follow up in regard.

  • Report this Comment On August 27, 2008, at 3:15 PM, AZErnie wrote:

    A grossly uninformed piece. It makes me wonder if Brian knows anything about the subject matter he writes in, or worse yet, he does and yet writes such blatently false information anyway!

    First, Tysabri is virtually universally praised by the MS patients who are on the therapy, not so with: copaxone, avonex, etc. who are mostly tolerated by thier patients. And whom suffer more than twice the relapses than those on Tysabri.

    Brian, instead of regurgitating the biased opinions of other bio-writers, consult with those who actually take the drug or perscribe it, you will find an entirely different world.

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