Hyundai Pharm gets nod for acne treatment Winlevi

Hyundai Pharm announced on Thursday that it has received marketing approval from the Ministry of Food and Drug Safety (MFDS) for its new acne treatment drug Winlevi Cream (clascoterone).

Winlevi is a topical treatment for acne in patients aged 12 years and older. It is already approved and sold in the U.S., Canada, Australia, New Zealand, the U.K., and Jordan.

Winlevi, a topical androgen receptor inhibitor, acts directly on the sebaceous glands to suppress sebum production and reduce the secretion of inflammatory cytokines. The company explained that its latest product differs from existing treatments in that its absorption into the body is limited, preventing systemic anti-androgen effects, and it can be used safely by both men and women.

In two phase 3 clinical trials involving over 1,400 acne patients, twice-daily topical application for 12 weeks demonstrated significant therapeutic efficacy compared to placebo, along with good tolerability and safety. Furthermore, results from a 12-month long-term extension study confirmed that Winlevi's efficacy increases over time.

Hyundai Pharm anticipates that the approval of Winlevi will provide a new treatment option for Korean patients requiring ongoing acne therapy.

“According to IQVIA data, Winlevi has become one of the most prescribed topical acne treatments since its launch in the U.S.,” a company official said. “Building on its proven efficacy and safety demonstrated overseas, this domestic approval will allow us to provide a new treatment option that can be safely applied to both men and women, addressing the unmet needs in acne treatment.”