The shares of Irish drugs company Elan Pharmaceuticals (ELN.N: Quote, Profile, Research) rose nearly 19 percent to $4.49 after the company and its partner Biogen Idec (BIIB.O: Quote, Profile, Research) reported for the first time full results from a pivotal-stage trial of their suspended multiple sclerosis drug Tysabri, showing it slows disability in relapsed MS patients. ---------------------------------------------- This is great news, but what part of doesn't matter with respect to FDA is not understood?
I'm having a lot of trouble factoring this result into the long term prospects of t RETURNING as a viable money maker.
>> This is great news, but what part of doesn't matter with respect to FDA is not understood?
>> I'm having a lot of trouble factoring this result into the long term prospects of t RETURNING as a viable money maker.
>> Help me understand....
They key here is not so much how good it is, it is how safe it is. The FDA looks mostly at the statistical benifit/risk ratio.
The risk shown in AFFIRM seems low or is even comparable to placebo. Statistically the low or non incidence of many opptunistic infections simply mean that the immunosuppression effect is minimal, at worst there is 'a bit'.
Other side effects, especially those that cause many significant disconformt (headaches, trembling, fever, insomnia, depressions etc) that you see so often at fairly high rates in other MS drugs is clearly lower. No obviously that's nice but not that important to the FDA, apart from the simpel fact that because other treatments have so many side effects the drop-out ratio is fairly high. And that does interest the FDA.
So the big point is that the safety data from AFFIRM seems so good that it clearly seems to indicate that Tysabri monotherapy is safe.
What about the PML cases then? Indeed what about them. We'll hear more about them tomorrow when the two cases that occurred in SENTINEL are discussed. If in that study we see clearly more opportunistic infections, then it probably means that the combo is less safe; it may also mean that the patient group is/was more sick.
As it is now I see Tysabri back (pretty soon) as monotherapy + (for now) general monitoring for OI's, monitoring for JCV (and probably BKV) and monitoring for suspicious low T-cell counts. And a moderate label change.