Priority Review Voucher Awarded to Biogen

FDA has awarded Biogen a priority review voucher (PRV)for gaining approval of rare disease drug Spinraza (nusinersen), indicated for treating spinal muscular atrophy in pediatric and adult patients. FDA has approved Biogen’s Spinraza (nusinersen) for treating children and adults with spinal muscular atrophy. Spinraza, the first drug indicated for this condition, is an injection administered into the fluid surrounding the spinal cord, FDA said in an announcement late last year. The voucher was awarded under a provision that encourages development of new drugs and biologics for rare pediatric diseases. With the passage of the 21st Century Cures Act, the PRV program has been extended through 9/2020.

Last month, Sarepta Therapeutics entered into an agreement to sell to Gilead its PRV for $125 million. Sarepta was awarded the PRV when it gained approval last year for its Duchenne muscular dystrophy drug Exondys 51.