FDA re-Approves Tysabri
By Johns Wu on Jun 05, 2006
As many of you know, I've been following Tysabri and Elan ever since this blog has been running, ever since ELN was $6.
Today, the whole issue has been resolved, as the FDA has cleared Tysabri to be remarketed to MS patients. As I speculated months ago, the whole issue with Tysabri was that it was unsuitable for immunosuppressed patients. Fortunately, routine screening of blood plasma should be able to screen for patients with abnormal immune function.
ELN and BIIB stock sold off sharply today because the FDA did not recommend Tysabri to be used as a first-line therapy. I am really disappointed by this ruling because it doesn't make sense to me. I've skimmed all the studies on Tysabri, and in my opinion, there is no reason that Tysabri doesn't deserve an "all-clear" exoneration from the FDA.
My impression from reading the FDA guidelines released today is that the FDA is still NOT CERTAIN on the exact mechanism of PML. Read question #4 to see what I mean. They've been reviewing clinical data for over 1 year, and this is the best explanation they can come up for PML. Sure, they know that it has to do with immunosuppression, but even I could have told you that a year ago. My opinion on the FDA's reluctance to give Tysabri their full blessing is that they are just trying to cover their ass!
Unfortunately, since the FDA has chosen not to recommend Tysabri for first-line treatment, I expect that analysts will be lowering sales estimates for the drug. (EDIT: Although the FDA has not recommended first-line treatment, patients who want it can still work with their physician to get it).
Oh well, at least today was a clear victory for the MS patients. I will also be watching tomorrow's ELN conference call for more clarification on today's ruling.
3 Responses to “FDA re-Approves Tysabri”
It’s not that it’s restricted to first or 2nd line use. It’s that due to the risks (ie the PML as discussed), that put the drug into a higher risk classification. That also makes it so that more paperwork and approvals are needed in order to get Tysabri.
There’s a whole host of other immunosuppresants out there that would have been used before Tysabri anyhow. Not to mention the classic first line choice is still corticosteroids.
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You too are confused y what was reported as many of us are: here is the truth: See ELN Yahoo msg Board as well; from the Board by totally credible poster:
First line/Second line
by: lovesjohndory 06/05/06 05:21 pm
Msg: 1026442 of 1026906
FDA’s Dr. Russell Katz, in a conference call with MS patients and patient advocacy organizations held at 4:00 pm this afternoon, stated that the first line/second line language was deliberately left ambiguous to leave that decision to the doctor and the patient. There are two grounds on which doctors and appropriate RRMS patients can decide to administer Tysabri, if the response to the CRABs has been “inadequate,” or the patient is “unable to tolerate” the CRABs. The doctor and patient can conclude the lack of comparable efficacy from the CRABs supports a decision to switch to Tysabri. They can also conclude, even in stable patients previously on CRABs who were getting injection site reactions or flu-like reactions that the patient is “intolerant” of the CRABs, and Tysabri can be prescibed.
I did not see any recommended “washout” period for the CRABs prior to initiating Tysabri therapy.
Insurance coverage may be an issue, but rest assured that BIIB, ELN and the medical community will learn to work with the insurance companies to get Tysabri (with insurance reimbursement) to those who want it.
One of the participants in the conference call was Susan Sanabria of NMSS, who was concerned about cognitively impaired patients being unable to make an informed decision. Dr. Katz responded that the patients guardian or caregive could assist in making that decision, and that most MS patients would have the ability to participate in the decisionmaking process.
BOTTOM line is TY is NOT restricted to first line use - I think you need to clarify this point. Wht has confused you is the way the press has reported it, and no thanks to the PR depts of ELN and BOOB!
Best,
Victor