Novo Nordisk is using its ticket for an extra-speedy regulatory review granted through the FDA’s Commissioner’s National Priority Voucher (CNPV) program on a higher-dose version of its obesity med Wegovy (semaglutide).
The 7.2 mg Wegovy dose is expected to “bring patients and healthcare professionals a new option for greater weight loss potential, further underlining the efficacy that the semaglutide molecule can bring,” Novo’s SVP of clinical development, medical and regulatory affairs, Anna Windle, Ph.D., said in the company’s Wednesday press release.
Thanks to the voucher, Novo should see the FDA's decision within one to two months. If approved in that timeframe, the nod could come in around the same time as the FDA’s expected fourth-quarter decision on Novo’s 25 mg oral semaglutide, which the company calls “Wegovy in a pill.”
In Novo’s phase 3 Step Up trial, once-weekly injections of high-dose semaglutide helped those with a mean baseline body weight of 249 pounds achieve an average weight loss of 20.7% after 72 weeks, compared to the 17.5% weight reduction seen in those who took a 2.4 mg dose of Wegovy and 2.4% for the placebo arm.
For those on the 7.2 mg version, 33.2% met a weight loss of 25% or more after the trial period, as did 16.7% in the 2.4 mg group and 0% on placebo.
Novo was awarded its voucher earlier this month for Wegovy, along with five other recipients among the second batch of CNPVs that includes Eli Lilly with its oral GLP-1 candidate orforglipron. The FDA has so far granted 15 CNPVs.
The vouchers are designated for “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, M.D., said in a Nov. 6 press release.
Makary and the FDA launched the priority program in June, offering an “unprecedented opportunity” for an ultra-fast review and reflecting the FDA’s commitment to “modernize regulatory frameworks.” Under the program, a multidisciplinary group of physicians and scientists will gather for a one-day team-based review that mimics the style of a “tumor board,” cutting down on both the typical review timeline of about 10 months and the six-month priority review period. Other benefits include “enhanced communications” with the FDA, it said.
Novo is also seeking regulatory reviews in Europe, where it expects a decision in the first quarter of 2026.
CNPV controversy
Criticism has already picked up around the CNPV program. In a Nov. 20 letter (PDF), two lawmakers, New Jersey Rep. Frank Pallone Jr., and Independent Vermont Sen. Bernie Sanders, outlined “deep concerns” about the program, which they said could “enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump.”
The letter probed Makary with 16 requests and questions that ask for information about recipients, further explanation of the agency’s “priority areas” and CNPV reviews, plus other questions. A spokesperson for the Department of Health and Human Services (HHS) told Fierce Pharma that the program “provides a clear incentive for investment in areas where innovation has lagged, while preserving the FDA’s rigorous standards for safety and effectiveness.”
The lawmakers also voiced concerns of “rushed reviews by an agency whose staff have been decimated by this administration’s cuts” that could “undermine public confidence in FDA’s decisions.”
As it turns out, the first iterance of an extra-speedy review under the CNPV program excluded those on the FDA review team, instead featuring high-ranking leaders at the agency, Stat reported last week.
Meanwhile, even top FDA leadership has raised concerns about the “legality and pace” of initiatives to speed up drug decisions, the Washington Post recently reported, mentioning the new director of the Center for Drug Evaluation and Research (CDER), Richard Pazdur, M.D., as one critic, according to the Post’s sources of three people familiar with the matter.
Elsewhere, several experts in government, policy and medicine called the program a “make-a-deal” between drugmakers and the Trump administration in a recent opinion piece in Stat, pointing to Lilly’s and Novo’s recent White House pricing deals as one example.
Novo and its obesity rival, Eli Lilly, both struck government pricing deals on the same day that they won the vouchers, agreeing to sell their weight loss drugs at a sharp discount to U.S. patients. For Novo, the pricing agreement covers Wegovy and diabetes med Ozempic.
Medicare patients will be able to access Novo’s and Lilly’s meds for $50 per month, President Donald Trump said in a press conference at the time. The deals also grants Lilly and Novo a three-year tariff relief period, the companies said.