FDA's Serono Approval Starts the MS Drug Wars Early

Let the multiple sclerosis drug wars begin.

Friday, Swiss biotech firm Serono (SRA Quote) said it has received Food and Drug Administration clearance to sell its MS drug, Rebif, in the U.S., allowing it to compete directly against rival Biogen (BGEN Quote) and its drug, Avonex.

Serono was able to use data that showed Rebif is superior to Avonex to break Biogen's orphan-drug status in the U.S. more than a year ahead of schedule. The orphan status grants seven years of market exclusivity to drug companies that develop expensive drugs for relatively rare diseases. Avonex's exclusivity was scheduled to expire in May 2003. ...