A hot commodity, the FDA’s Rare Pediatric Disease Priority Review Voucher program once again proved its worth, with today’s $245m transaction.
A hot commodity, the FDA’s Rare Pediatric Disease Priority Review Voucher program once again proved its worth, with today’s $245m transaction. Retrophin, who obtained the voucher in its March acquisition of Asklepion Pharmaceuticals will receive $150m now and a pair of $47.5m installments in 2016 and 2017.
Sanofi is footing the bill, and time will tell how the French pharma giant will use the FDA's IOU. The voucher promises accelerated progression towards approval for the asset of the holder’s choosing from 10 months to 6 months.
Regeneron famously obtained a voucher from Biomarin for $67.5m and will use it to goose its cholesterol lowering PCSK9 Praluent (alirocumab), which is partnered with Sanofi, in the race to be first to market against Amgen’s evolocumab.
One biopharma Twitter commentator contends that Sanofi is motivated by the cholesterol market and the dynamics engendered by payer activism.
Sanofi and Amgen probably going halfsies on this Retrophin PRV to keep it away from Pfizer. 2 PCSK9s = less payer leverage than 3 PCSK9s
- Chris Morrison (@CT_Morrison) May 27, 2015
FDA Approves AbbVie’s Emblaveo for Complicated Intra-Abdominal Infections
February 11th 2025Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be approved by the FDA for complicated intra-abdominal infections with limited treatment options.
FDA Approves Supernus Pharmaceuticals’ Onapgo for Managing Motor Fluctuations in Parkinson Disease
February 7th 2025Approval of Onapgo (apomorphine hydrochloride) marks the first and only subcutaneous apomorphine infusion device for managing motor fluctuations in adults with advanced Parkinson disease.