Novo Nordisk gets FDA okay for Wegovy pill
Production of Wegovy pills 25 mg.
The FDA has delivered a gift to Novo Nordisk ahead of the holiday season, with the prompt approval of an oral formulation of its blockbuster weight-loss therapy Wegovy.
The green light for the first oral GLP-1 agonist drug for weight loss gives Novo Nordisk a potentially valuable lead in what is shaping up to be the next big battleground in the obesity market, and shares in the company were up around 8% at the time of writing.
The FDA-approved label covers use of the drug to reduce excess body weight, maintain weight reduction long-term, and to reduce the risk of major adverse cardiovascular events (MACE) associated with being overweight.
Once again, the two main protagonists in the oral GLP-1 category are Novo Nordisk and Eli Lilly, which currently share a duopoly on injectable GLP-1 therapies.
Lilly is also anticipating approval from the FDA very soon for its oral GLP-1 orforglipron, thanks to a national priority review voucher that will reduce its regulatory review to a matter of weeks.
Novo Nordisk said it is ramping up manufacturing of the Wegovy (semaglutide) pill in anticipation of launching the drug in the US early next month, and is clearly hoping to make headway while it has the oral market to itself.
"The pill is here. Patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection," said Mike Doustdar, who took over as president and chief executive of Novo Nordisk earlier this year to turn around a business that grew massively on the back of weight-loss therapies but has started losing ground to Lilly.
The approval is based on the OASIS 4 trial, which revealed an average weight loss of 16.6% with a 25 mg dose of oral semaglutide given once daily, with comparable results on secondary measures – such as the proportion of patients experiencing 20% or greater weight loss – compared to once-weekly injectable Wegovy
Analysts have suggested that the availability of oral alternatives to injectable GLP-1 drugs could expand access and lead to a huge increase in usage, particularly among cash purchasers.
"No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill, and we are very excited for what this will mean for patients in the US," added Doustdar.
The new oral version will be available at a price of $149 per month following negotiations between Novo Nordisk and the Trump administration, and the company has previously said it will make the drug available widely through its direct-to-consumer (DTC) sales channels.
There are differences between oral Wegovy and orforglipron that could have a role to play in determining which of the drugs will lead the oral category. For example, Wegovy needs to be taken first thing in the morning on an empty stomach, half an hour before eating or drinking, while orforglipron does not need those restrictions.
Novo Nordisk has also filed the Wegovy pill in Europe and is expecting to hear back from regulators there in the latter half of 2026.
