FDA Fast-Tracks 6 More Drugs - Obesity And Cancer Drugs Included
On Thursday, the U.S. Food and Drug Administration (FDA) announced six additional awardees under the Commissioner's National Priority Voucher (CNPV) pilot program.
Ø Boehringer Ingelheim Pharmaceuticals Inc.'s – Hernexeos (Zongertinib) for HER2 lung cancer.
Ø Johnson & Johnson's – Sirturo (Bedaquiline) for drug-resistant tuberculosis in young children.
Ø GSK Plc's – Jemperli (dostarlimab) for rectal cancer.
Ø Vertex Pharmaceuticals Inc.'s – Casgevy (exagamglogene autotemcel) for sickle cell disease
Ø Eli Lilly and Co.'s – under development Orforglipron, an oral drug for obesity and related health conditions.
Ø Novo Nordisk A/S' – Wegovy (semaglutide) for obesity and related health conditions.
The second cohort brings the total number of voucher recipients to 15, underscoring the agency's commitment to accelerating the review of products with the potential to address key national priorities.
"National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need," said FDA Commissioner Marty Makary.
