This article is part of our series on the FDA’s National Priority Voucher program, exploring the therapies selected, their potential impact, safety considerations, and what accelerated review could mean for patients in the US and globally.
In November 2025, the FDA announced the addition of six more awardees under the Commissioner’s National Priority Voucher program. The voucher allows companies to receive a decision on their product in just one to two months compared to the usual 10–12 months. Two of the six went to glucagon-like peptide-1 (GLP-1) drugs: Novo Nordisk’s Wegovy, an injectable form of semaglutide, and Eli Lilly’s orforglipron, a novel oral non-peptide small molecule. These vouchers followed agreements from Novo Nordisk and Lilly to cut prices on the drugs for Medicaid and Medicare patients.
Since Wegovy is already FDA-approved, Novo Nordisk announced on November 26th that they have filed their voucher for approval of a higher-dose version at 7.2mg.
Lilly’s orforglipron, on the other hand, has not been FDA approved. Lilly said earlier this year that they have plans to submit for approval of the drug by the end of the year.
“I am somewhat surprised about the timeline of just two months for both of these medications.”
– Michael Camilleri, Mayo Clinic
Experts in the GLP-1 field and physicians who prescribe the drugs are excited about the opportunity for rapid and expanded options for patients. “GLP-1 medicines have been game changers for treating obesity and these therapies are increasingly prescribed by practitioners that treat obesity. Providers eagerly await some new innovations in our GLP-1 medicine armamentarium and the FDA's National Priority Voucher Program will hopefully lead to rapid approvals of such drugs so that these therapies can be brought to market in a timely fashion,” Ronald Goldenberg, consultant endocrinologist emeritus at LMC Diabetes & Endocrinology, told DDN.
Others expressed potential concerns about the speedy review timeline, however. “I am somewhat surprised about the timeline of just two months for both of these medications,” said Michael Camilleri, a gastroenterologist at Mayo Clinic. He added that his surprise doesn’t stem from any concerns over the mechanism of action for the two drugs, but rather because orforglipron has not gone through the extensive evaluation of adverse effects since it’s not approved yet. Plus, for Wegovy, he’s not sure that there’s enough of a clinical need for it based on the clinical trial results so far.
A higher-dose Wegovy
In a press release, Novo Nordisk highlighted the potential for their higher-dose Wegovy to lead to even greater weight loss benefits for patients. “If approved, semaglutide 7.2 mg would bring patients and healthcare professionals a new option for greater weight loss potential, further underlining the efficacy that the semaglutide molecule can bring. We look forward to working with the FDA to bring this fast-tracked option to the obesity community,” said Anna Windle, Senior Vice President, Clinical Development, Medical and Regulatory Affairs, Novo Nordisk.
The two Phase 3 trials of the higher-dose version compared the efficacy and safety of once-weekly semaglutide 7.2mg to semaglutide 2.4mg over 72 weeks and showed that individuals with obesity, with or without type 2 diabetes, lost around 3 percent more of their body weight. “This additional weight loss of over three percent is considered clinically relevant, especially for individuals who would benefit from further weight loss,” said Goldenberg.
Camilleri, on the other hand, said that the three percent difference was relatively small. He also pointed out the higher dose led to a greater incidence of dysasesthesia — a condition characterized by abnormal pain sensations — which he said “as far as I am aware are a relatively new adverse event with this class of compounds and deserves further investigation, including further evaluation of nerve conduction studies to ensure that there is no adverse effect on peripheral sensory nerves.” Camilleri noted evidence that GLP-1 receptors are present on peripheral sensory nerves as additional justification to thoroughly evaluate safety data related to sensory nerve function.
Daniel Drucker, an endocrinologist at the Lunenfeld-Tanenbaum Research Institute, added that the additional weight loss will be attractive for some, though it will need to be weighed against the side effects. “As we achieve greater weight loss with any GLP-1 medicine, greater adverse events are common. Hence, each discussion with each patient will need to discuss goals, risks versus benefits, and decide on the best medicine and the most appropriate target dose,” he said.
A novel oral GLP-1 option
In contrast to the already-approved Wegovy, the voucher for Lilly’s orforglipron represents a novel drug approval. As such, experts shared more concerns about the review team having enough time for a rigorous review.
“It is not the length of the review process that is paramount, it is the quality of the review and the diligence of the reviewers.”
– Daniel Drucker, Lunenfeld-Tanenbaum Research Institute
“Orforglipron is the first of several small molecule oral GLP-1 medicines. Hence it has great potential to broaden access and affordability, but of course, one cannot fully predict the [adverse event] profile for each small molecule so scrutiny of the totality of the safety data for orforglipron is very important,” said Drucker.
Drucker added, “For me, it is not the length of the review process that is paramount, it is the quality of the review and the diligence of the reviewers. I am not certain that the length of time it takes to review a drug always correlates with the quality of the review process, I have not seen data about this.”
If approved, however, Goldenberg pointed to many potential advantages of the drug. “It is quite easy to administer, without any timing restrictions related to food or time of day. It is relatively easy to manufacture and it is expected to be more affordable than currently available GLP-1 medicines,” he said.
