'The pill is here': Novo Nordisk get USFDA nod for oral weight-loss therapy

oral pill

Novo Nordisk has secured approval from the US drug regulator for its Wegovy pill, marking the first oral therapy for weight management,  the Danish drugmaker said on December 23, a move that could reshape the obesity drug market.

“The pill is here,” said CEO Mike Doustdar, touting the approval as a breakthrough for patients seeking simplicity without sacrificing efficacy.

A pill is a more convenient alternative to the once-in-a-week injection regimen.

The once-daily semaglutide tablet demonstrated a 16.6 percent average weight loss in the OASIS 4 trial, matching results from the company’s blockbuster injectable version. A pill form is a more convenient alternative to injections.

The US Food and Drug Administration greenlight covers adults with obesity or overweight and at least one weight-related condition, with an added indication to lower cardiovascular risk. One in three trial participants shed 20 percent or more body weight, reinforcing the drug’s potential to rival bariatric surgery outcomes, it said.

Novo Nordisk said it plans US rollout in early January.

The Danish drugmaker has also filed for European approval and expects global uptake to accelerate amid surging demand for obesity treatments. Wegovy’s oral format could expand access and ease adherence, a critical factor as GLP-1 drugs dominate headlines and investor portfolios.