Dive Brief:

• Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss drug in obesity earlier this year, a spokesperson confirmed to BioPharma Dive. 
• Novo first reported in 2023 that the drug, an oral form of semaglutide, succeeded in a Phase 3 trial, helping people on the highest dose lose about 15% of their body weight after 64 weeks. However, the Danish drugmaker didn’t seek approval immediately afterwards, instead focusing attention on other medicines that might improve upon the injectable drug it sells as Wegovy for obesity and Ozempic for diabetes. 
• The approval filing comes as a race with rival Eli Lilly to develop a weight loss pill has intensified. Lilly last week said its oral GLP-1 pill succeeded in a large trial in diabetes. That drug, orforglipron, could be submitted to regulators if an ongoing study in obesity also meets its objectives. 

Dive Insight:

Drugmakers are scrambling to grab a share of a market that could top $100 billion annually next decade, and pills that can spur meaningful weight loss are a big part of those plans. 

Novo has long appeared to be well ahead of others in that race. It had already developed Rybelsus, an oral formulation of semaglutide, for diabetes, and began testing a higher-dose version of it in obesity. And in May 2023, it reported success in a study that tested as high as a 50 milligram oral dose of semaglutide. 

In a statement at the time, the company said it intended to seek approval in the U.S. and Europe in 2023. Yet in an earnings report shortly afterwards, Novo conceded that a launch was “contingent on portfolio prioritizations and manufacturing capacity.” The company has several would-be obesity drugs in clinical development, including a closely watched combination therapy called CagriSema. And unlike Lilly’s orforglipron, oral semaglutide is a peptide drug, making its production more complicated than a traditional small molecule. 

However, CagriSema’s progress has been slowed by disappointing study results that have forced Novo to redraw its development plan. Another oral prospect has also underwhelmed.

Through a series of investments, Novo has finally begun to make enough of Wegovy to meet demand, easing a supply shortage that’s lasted for years. Yet the 25 milligram daily dose involved in the oral version — around 70 times the top dose of Wegovy — could once again test its production capacity. 

Novo’s executive team will provide more details about the approval application alongside the company’s first quarter earnings report on May 7, the spokesperson said.