RE: FDA Approval Research22 Jul 2020 20:43
J Diamond
Thxs for the attachments, which i looked at in detail.
Avonex , Plegridy and Rebif - All three are injectable Interferons as you said , and have restricted use for multiple sclerosis and its variants . As you may recall one of the reasons for MS is autoimmune disorder .
All 3 drugs have been approved right from 1996 and their variants as late as May2020. They have various side effects and hence need to be looked into further for inhalatory/ topical use as a spray for example.
There is no reason why the FDA should have a problem given the current situation and the past therapeutic application. The only clearance needed is the mode of use of B interferon with study of side effects.
Now comes the critical point - if the patients are have covid and likely to become critical aor are already critical facing life threatening situation the only treatment currently proven in such cases is B interferon and steroids., together or on their own. Side effects would be dose dependant and as such FDA or others may recommend
- a monitored dose
- monitoring side effects to organ systems .
OR ELSE medical teams have no other option IMO
Dont forget the need for emergency approval in this situation - I will not be surprised if we have this in next 10 days or so.
Cheers
MK