CORRECTED-UPDATE 1-US FDA awards six more fast-track vouchers to speed drug reviews

Reuters
11/07
CORRECTED-UPDATE 1-US FDA awards six more fast-track vouchers to speed drug reviews

Corrects to say Johnson & Johnson owns bedaquiline, not Takeda, and Boehringer Ingelheim owns zongertinib, not BeiGene, in paragraph 4

Nov 6 (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.

The recipients include Novo's NOVOb.CO weight-loss drug Wegovy, Lilly's LLY.N experimental obesity pill orforglipron, and Vertex Pharmaceuticals' VRTX.O gene therapy Casgevy for sickle cell disease.

Also selected were: GSK's GSK.L dostarlimab for rectal cancer, Johnson & Johnson's JNJ.N bedaquiline for drug-resistant tuberculosis in young children, and Boehringer Ingelheim's zongertinib for a type of lung cancer.

The vouchers are part of a pilot program called the Commissioner's National Priority Voucher that was launched in June. Companies that receive them can get a decision on their drug applications within one to two months instead of waiting the typical 10 to 12 months.

"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," FDA Commissioner Marty Makary said in a statement.

The FDA announced its first batch of nine vouchers in October.

(Reporting by Kamal Choudhury in Bengaluru; Editing by Alan Barona)

((Kamal.Choudhury@thomsonreuters.com;))

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