2010 is around the corner; what can we look forward to?
Let's focus on the hot topic -- Fampridine-SR or Amaya:
In the past, we have clarified that Amaya is (unfortunately) not FDA approved yet (there seems to be a lot of confusion about this fact) as the PDUFA (prescription drug user fee act) date has been pushed off to January 22, 2010 (3 months from the original October 22, 2010 PDUFA date).
The reason for this is that Acorda (ACOR) wanted to work with the FDA on the development of an appropriate risk evaluation and mitigation strategy (REMS).
Hopefully, though, this deferment will give Acorda and the FDA time to reach an agreement regarding approving Amaya prior to the need for a lower dose (5 mg) study. [Interestingly in my patients on compounded 4-aminopyridine had more headaches on 5 mg, when I used to titrate it, as opposed to on 10 mg.]
So, what can we as the MS community to help the FDA along in approving Amaya? This is needed because, despite what patients and neurologists know -- i.e. that it helps people function better, the FDA is in no rush to approve this drug.
The MS community mobilized itself in trying to get Tysabri (natalizumab) re-released in 2006, by descending on the FDA hearing etc..
Where is that same community now?
Where is Sanofi-Aventis (SNY) in all this?
Sanofi-Aventis could benefit the MS community by helping the FDA understand to approve a medication that could improve neurological functioning. This may sound like a surprising challenge -- after all they are developing a competitive product (Nerispirdine, which affects both potassium and sodium channels); this would allow Sanofi-Aventis an reentry into the MS market (Aventis and its relationship with Teva on Copaxone or glatiramer acetate), it would help patients and it would be a nice way to show that Sanofi-Aventis is committed to MS.
So, even though it is an (eventually) competitive product, it would be free de facto advertising (like this blog) for Sanofi-Aventis and wouldn't hurt them because they are going to be facing the same challenges when they are ready to face the FDA.
As always, collaboration is key.
Medical Director
Neurologique
info@neurologique.org
www.neurologique.org
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I have been following your Tweets for a little while now and had finally subscribed to them. Now I see that you are the same Dr. Kantor who used to write at HealthCentral with me. Well, we overlapped for about 6-7 months anyways.
ReplyDeleteJust good to put 2+2 together.