FDA approves higher Wegovy dose via 4th priority voucher
The US FDA has approved a fourth product via its new National Priority Voucher Programme -- a 7.2 mg dose of Novo Nordisk's weight loss drug Wegovy (semaglutide), to be marketed as Wegovy HD. This time the time from approval to filing was just 54 days according to the agency.
“The new FDA is moving with unprecedented efficiency on products that advance national priorities,” said FDA Commissioner Dr Martin Makary. “Today’s approval is another demonstration of what the FDA can accomplish when we try bold new things.”
The new formulation was approved based on data from the STEP UP trial, where it generated 20.7% mean weight loss in a study of 1400 patients, compared to 17.4% with a standard 2.4 mg dose. The safety and tolerability profile was comparable to the lower dose as well.
Wegovy HD will be available in a single-dose pen for once-weekly injection starting next month, Novo Nordisk said in a statement.
"With the accelerated approval of Wegovy HD, we are introducing a new offering for our injectable semaglutide that provides even greater weight loss of approximately 21%," Novo Nordisk CEO Mike Doustdar said in a statement. "At Novo Nordisk, our goal is to provide innovative therapies that support healthier lives for people living with obesity, and we look forward to launching Wegovy HD to help even more people reach their weight and health goals.”
Wegovy is currently available in the United States as a 25 mg daily pill and 1.7 mg and 2.4 mg weekly injections. In Europe and the UK, the 7.2 mg dose is already approved for use, but a dedicated once-weekly pen for that dosage is not -- that approval is expected later this year, according to Novo Nordisk.
Novo Nordisk was granted the voucher in November of last year, around the same time the results of the STEP UP trial were pubished in the Lancet.
The Commissioner's National Priority Voucher programme is a pilot programme to expedite approval of drugs that "address critical national health priorities, such as bringing innovative therapies to the American people, addressing large unmet medical needs, promoting domestic manufacturing, and increasing affordability." It was announced last year.
