First in 40 years! FDA Approves innovative acne drugs
on August 27 local time, Cassiopea company released a news on its official website that FDA approved the listing of winlevi (clascoterone, 1% emulsion) for the treatment of acne patients aged 12 and over. This is the first acne drug with innovative mechanism approved by FDA in 40 years. It is expected to be listed in the United States in early 2021.
According to the official website, acne is a multifactorial skin condition, which is affected by four different ways: excessive sebum, pore blockage (excessive keratinization), bacterial growth and inflammation. For the external treatment of androgen, androgen promotes the production of sebum and inflammation to a great extent. So far, there is an obvious unmet demand in the acne treatment market.
Clascoterone (1% emulsion) is the first external androgen receptor inhibitor. It can compete with androgens, especially dihydrotestosterone (DHT), combine with androgen receptors in sebaceous glands and hair follicles, block the downstream signal pathway of androgen receptors, and prevent excessive sebum secretion and inflammation. In key clinical trials, winlevi demonstrated the success of treatment and the reduction of acne lesions, and was well tolerated twice a day. The most common local skin reaction is mild erythema.
The topical drug of this change therapy provides a non antibiotic treatment for acne patients by directly targeting the androgen receptor in the skin, which fills the long-term gap of acne treatment.
