Hims & Hers Halts Wegovy Knockoff Launch Amid FDA Pressure
In response to pressure from the Food and Drug Administration (FDA), Hims & Hers has decided to discontinue its launch of a Wegovy knockoff weight-loss drug. The announcement followed the FDA’s warnings about illegal copycat medications in the marketplace.
FDA Takes Action Against Copycat Drugs
The FDA issued stern statements, highlighting the importance of consumer safety. The agency noted that it could not verify the safety, quality, or efficacy of certain medications. Hims & Hers was specifically named in the FDA’s announcement, which underscored the seriousness of potential violations of the Federal Food, Drug, and Cosmetic Act.
Hims & Hers Responds
On Saturday, the telehealth company issued a statement reflecting constructive discussions with industry stakeholders. As a result, they have opted to halt access to their compounded semaglutide pill.
Novo Nordisk’s Legal Concerns
Hims & Hers’ decision comes amid threats from Novo Nordisk, the original manufacturer of Wegovy, to pursue legal action against the company. Novo’s weight-loss pill has not received FDA approval for Hims’ version nor undergone clinical trials.
Pricing and Market Landscape
Initially, Hims & Hers planned to offer its compounded version of Wegovy for an introductory price of $49 a month. This price point was significantly lower than the original version, making it the most affordable GLP-1 weight-loss drug on the U.S. market. However, the FDA’s interjection has complicated this launch.
- Hims & Hers: Planned a Wegovy knockoff launch.
- FDA: Threatened action against illegal copycat drugs.
- Novo Nordisk: Expressed intention to pursue legal action.
- Initial Price: $49 per month for the compounded drug.
The Impact on Hims & Hers’ Shares
After the announcement of its Wegovy knockoff, shares of Novo Nordisk experienced a brief decline but later recovered. Conversely, shares for Hims & Hers fell following the FDA’s warning.
Future of Telehealth and Compounded Drugs
Hims & Hers has not confirmed if it will continue selling its compounded GLP-1 injection on its platform. The company’s previous partnership with Novo allowed them to sell Wegovy before accusations of marketing a knockoff surfaced.
As the landscape of weight-loss drugs continues to evolve, companies like Hims & Hers face increasing scrutiny. The FDA’s role in regulating these medications is vital for ensuring consumer safety.
