Novo Nordisk Seeks FDA Approval for Oral Wegovy

COPENHAGEN, Denmark (AP) — Novo Nordisk, a Danish pharmaceutical company, announced⁤ Friday it anticipates a decision from the U.S. Food and Drug Governance (FDA) in the fourth quarter regarding⁢ its marketing request for an oral version of its weight-loss ⁣drug,Wegovy.

Potential Game changer in Weight Management

If approved, the once-daily oral‍ medication ‍would be the first⁤ oral GLP-1 (glucagon-like peptide-1) receptor agonist for chronic weight management. Currently, GLP-1 drugs are primarily administered via injection.

Stock Market Reaction

Following the announcement, Novo Nordisk’s U.S.-listed stock (NOVO) experienced a surge,closing at $69.36, a ‍5.72% increase for the session.

Rybelsus: A Precursor

novo Nordisk already markets ⁢Rybelsus, an oral GLP-1 drug containing semaglutide, the same active ingredient as Wegovy. Rybelsus is approved for blood sugar⁤ control in adults with type 2 diabetes.

The⁤ Race for ‍Oral Obesity Treatments

Novo Nordisk and Eli Lilly, along with other pharmaceutical companies, are engaged in a competitive race to‍ introduce convenient ⁢oral weight-loss medications. This push comes amid expectations that the ‍obesity drug market could reach $150 billion in⁤ sales within the next few years, a market currently dominated by injectable medications.

Eli⁣ Lilly’s Orglifon Shows Promise

Last month, Eli Lilly ⁢reported that Orglifon,⁣ an experimental drug, helped patients lose an average of 16 pounds, or nearly 8% of their body weight, over ‍a 40-week period. ⁣The company‍ plans to⁣ release additional ‍clinical‍ trial data on its weight management drugs later this year and intends to seek regulatory approval for weight loss and diabetes treatments globally in the coming years.

Eli Lilly markets its injectable tirzepatide ⁢under‍ the ⁣brand names Mounjaro⁣ for diabetes and Zepbound for weight loss.

Wegovy Application ⁣Details

novo Nordisk’s application to⁤ the FDA is supported by results from⁣ late-stage clinical trials. These trials studied a ⁤25-milligram⁤ oral semaglutide dose compared to a placebo in 307 adults with obesity and ‍at least one co-existing health condition.

Further Research and Development

The company is also exploring amylin, a pancreatic hormone, in conjunction with GLP-1, the same intestinal hormone ⁢mimicked by Wegovy. Both subcutaneous and other versions are being tested.

Investor Concerns

Novo ⁣Nordisk has faced‍ pressure ⁣from⁤ investors due⁤ to concerns about ⁤the performance of CagriSema, a next-generation weight-loss drug candidate initially⁤ expected to ⁢be a strong successor to Wegovy.