By Kamal Choudhury (Reuters) -The U.S. Food and Drug Administration said on Thursday it has awarded six more companies, including Eli Lilly and Novo Nordisk, special vouchers that will speed up the review of their medicines, bringing the total number of recipients to 15. The vouchers went to treatments for cancer, obesity, tuberculosis and sickle […]
Health
US FDA awards six more fast-track vouchers to speed drug reviews
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By Kamal Choudhury
(Reuters) -The U.S. Food and Drug Administration said on Thursday it has awarded six more companies, including Eli Lilly and Novo Nordisk, special vouchers that will speed up the review of their medicines, bringing the total number of recipients to 15.
The vouchers went to treatments for cancer, obesity, tuberculosis and sickle cell disease.
Among the selected products are Novo’s oral version of weight-loss drug Wegovy and Lilly’s experimental obesity pill orforglipron.
The vouchers are part of the Commissioner’s National Priority Voucher, a pilot program launched in June to accelerate FDA decisions for drugs that address key public health or national security needs. Companies that receive a voucher can expect a decision within one to two months, compared to the typical 10 to 12 months.
The announcement coincided with the Trump administration unveiling pricing agreements with the two drugmakers for their weight-loss treatments. In exchange for lowering prices for Medicare and Medicaid, both companies received priority review vouchers.
Michael Leuchten, an analyst at Jefferies, said the vouchers are “unlikely to favor Novo.”
Leuchten added that since approval for Novo’s oral Wegovy is already anticipated before year-end, “the benefit of this voucher appears more modest to Novo.”
Shares of Lilly closed up just over 1%, while U.S.-listed shares of Novo Nordisk fell 4% on Thursday.
The recipients also included Vertex Pharmaceuticals’ gene therapy Casgevy for sickle cell disease, GSK’s dostarlimab for rectal cancer, Johnson & Johnson’s bedaquiline for drug-resistant tuberculosis in young children, and Boehringer Ingelheim’s zongertinib for a type of lung cancer.
FDA Commissioner Marty Makary said the vouchers are awarded to companies that commit to making their drugs more affordable, manufacturing them in the U.S., or addressing unmet health needs. “We are pioneering new ways of bringing these cures and meaningful treatments to the market faster,” he said.
The FDA announced its first batch of nine vouchers in October.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Alan Barona)