Protocols

Doctors Without Borders say FDA’s PRV incentive is misused; Teva drug wins FDA OK on tardive dyskinesia

⇨ A nonprofit group including Chemo Group won the first FDA approval for an old Chagas drug, pledging to make it available at low cost to patients. But Doctors Without Borders (MSF) says the priority review voucher they won in the process — likely worth more than $100 million — simply underscores how badly that incentive has worked for patients. “The fact that a company can receive an innovation award for registering a medicine that has been used to treat Chagas for years shows how far removed we are from the original intent of this program,” said Jennifer Reid, advocacy and research officer at MSF. “People suffering from Chagas and other neglected diseases still desperately need innovation and new research to save their lives and improve treatment and prevention options. They should be able to use and afford these medicines no matter where they live. Before a company can receive this prize, U.S. Congress should mandate that only new medicines receive a PRV and that companies ensure access and affordability for all patients.”

Teva has picked up an FDA OK to market Austedo — already approved for Huntington’s chorea — as a new therapy for tardive dyskinesia. Neurocrine Bioscience’s rival Ingrezza (valbenazine) beat Teva to the market for tardive dyskinesia last April with an FDA OK of its own.

⇨ With its stock nearly worthless and running out of cash, Bethesda, MD-based Immage Biotherapeutics $IMMG says it will close up shop and disband.


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