FDA gives Novo Nordisk’s Wegovy the green light for treating obesity

The pharmaceutical giant pushes to have its drug on pharmacy shelves as soon as this month.

After Novo Nordisk received the long-awaited FDA approval for Wegovy last week, the drug maker immediately began preparing for its launch. Wegovy (Semaglutide) is a once-weekly injection that helps with chronic weight control when combined with diet and exercise. It’s the first drug to get approval for this disease since 2014. Semaglutide was originally approved in 2017 to help control blood sugar in people with type 2 diabetes under the trademark Ozempic. People who took Ozempic tended to lose weight as an added benefit. Therefore, Novo Nordisk studied the drug in people without diabetes, but in higher doses. Now, Semaglutide under the brand name Wegovy has been approved by the FDA for weight loss in adults.

Novo's head of business strategy and corporate affairs, Camilla Sylvest, said in a conference call with investors that the drug will be available in pharmacies on June 18th. Up until then Novo, has organized doctor events to promote and publish the product and to spread the word, even launching a physician education site. Novo also revealed, the drug will be injected subcutaneously and will be paired with its very own single-dose drug delivery device. Novo is already planning a more convenient dosage method. For this year, the company aims to initiate a 1000 subject phase 3a trial to evaluate the safety and efficacy of 50mg oral Semaglutide versus placebo in overweight or obese comorbid patients.