ACOR/Fampridine-SR
The author neglected a few important points IMO:
The drug has successfully completed two SPA-supported
phase III trials. In its 1st study it met all three predefined efficacy outcome measures. Its effect was seen in all four MS types (PPMS, SPMS, RRMS, PRMS).
The FDA granted the drug a priority review (Acorda had not requested that). So the FDA finds the drug to be addressing an unmet medical need, and/or being a significant improvement over the current SOC.
The drug has a long history of off-label use.
On a side note: a delay is likely since the FDA panel schedule to be on Oct. 14, too close to the PDUFA.
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