Cassiopea scores FDA approval for Winlevi, the first novel acne med in decades

It’s been decades since a novel acne treatment hit the scene, but that’s set to change with Cassiopea’s approval for Winlevi.  

The FDA on Thursday approved the new prescription acne medication, set for use in people 12 and older.

Acne affects around 50 million people in the U.S., but there hasn’t been a new mechanism of action in the field in nearly 40 years, Cassiopea CEO Diana Harbort said ahead of the approval. Winlevi is a “first-in-class topical treatment” to treat acne at the “hormonal level for both males and females,” she added. 

The company expects dermatologists will use Winlevi in combination with existing treatments to address multiple facets of the condition, such as clogged hair follicles and inflammation. Doctors have indicated they’re enthusiastic about the new option, Harbort said, and the company expects “widespread acceptance and use.” 

They'll still have to wait a while, though; Cassiopea isn’t expecting to launch its new medication until next March. In the meantime, the company is meeting with payers and incorporating lessons from other companies that have launched during the pandemic to prep for its own rollout. 

For its commercial debut, the company is planning to balance in-person physician education with a digital component, the CEO said. The field force could comprise around 70 staffers, but Cassiopea expects to refine its plans over the next few months.  

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When Cassiopea launches Winlevi, the new drug will face off against branded options from Galderma, Bausch & Lomb and Menlo. 

Behind Winlevi, the company is also advancing pipeline candidates against hair loss and genital warts, as well as an antibiotic against acne. Cassiopea is a 2015 spinoff of Cosmo Pharmaceuticals.