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 Grants Priority Review to GSK’s Gepotidacin for Uncomplicated Urinary Tract Infections
October 18th 2024Priority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin in uncomplicated urinary tract infections.
FDA Approves Expanded Indication for Lumryz in Pediatric Patients with Narcolepsy
October 18th 2024Expanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that often require multiple doses throughout the night.