Cassiopea submits a new mechanism acne therapy application to fda

today, cassiopea, which specializes in developing new mechanism dermatology therapies, announced that it has submitted a new drug application (nda) to fda for the treatment of acne for its "first-in-class" local androgen inhibitor, clascoterone 1% cream. If approved by fda, it would be the first acne treatment with a new mechanism in nearly 40 years, the press release said.Acne, also known as acne, is a chronic inflammatory skin disease that often occurs in the skin lipid glands and hair follicles, with symptoms divided into inflammatory (papules and abscesses) and non-inflammatory (open and lax acne), which can severely affect the face and other skin areas. About 4-50 million people in the United States suffer from acne, of whom more than 10 million are moderate to severe. Acne can have an impact on the normal life and mental health of patients.is designed to be an effective and safe local androgen inhibitor without systemic side effects for the treatment of acne or androgen hair loss. The small molecule clascoterone penetrates the skin, acting on androgenics in the sebum glands and hair follicles, inhibits the secretion of sebum gland lipids and reduces the release of inflammatory cytokines by inhibiting local action of testosterone (dht), a key driver of acne lesions. Unlike oral hormone acne therapy, clascoterone can be used in both male and female patients.
nda's application is based on the results of two key Phase 3 clinical trials. The results showed that clascoterone significantly improved acne conditions. Follow-up results showed that in the 52nd week, 57% and 62% of the subjects achieved an improvement of more than two points in the researcher's overall score (iga) to achieve skin symptom removal (0 points) or basic removal (1 point). In addition, clascoterone demonstrates good safety and tolerance. (
medicine Mingkangde
)