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.