The first new mechanism acne drug in 40 years! Local androgen inhibitor Winlevi emulsion approved by FDA!

August 28, 2020 // -- Cassiopea is a pharmaceutical company dedicated to the development and commercialization of prescription drugs for skin diseases with new mechanisms of action (MOA).
recently, the company announced that the U.S. Food and Drug Administration (FDA) has approved The Winlevi (clascoterone 1%) emulsion for the treatment of acne in patients 12 years of age and older.
the drug is expected to be available in 2021.
acne is the most common skin disease in the United States, affecting 50 million people a year, but the last time the FDA approved an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago.
Winlevi is the first FDA-approved acne drug with a new mechanism of action (MOA) in nearly 40 years, providing dermatologists and patients with a new and effective treatment.
different from the oral hormones used to treat acne, the clascoterone 1% emulsion can be used in both male and female patients.
acne is a multi-factor skin disease affected by four different path pathfages: excessive secretion of oils (sebum), clogging of pores (excessive angularization), bacterial growth (acne rod bacteria), inflammation.
androgen-targeted local treatment options are an important requirement in the acne treatment market, and androgens largely drive sebum production and inflammation.
Winlevi's approval is an exciting breakthrough in acne treatment," said Michael Gold, a researcher and medical director at the Gold Skin Health Center and the Tennessee Clinical Research Center.
this game-changing topical drug provides a non-antibiotic approach by directly targeting androgens in the skin.
it fills a long-standing gap in acne treatment.
40 years since the last new mechanism acne drug was approved, Winlevi offers a much-anticipated and complementary new approach to the treatment of acne.
"clascoterone is a pioneering (first-in-class) exo-hormone-inhibitor designed to address the androgen components of acne in both men and women.
androgen inhibitors is to limit the role of these hormones in increasing inflammation in sebum secretion.
clascoterone is a small molecular drug that penetrates the skin to reach androgens in the sebum glands and hair follicles, and is the first safe and effective local androgen inhibitor therapy without systemic side effects.
clascoterone 1% emulsion is used locally, 2 times a day, acting on androgens at the drug site, inhibiting the local (skin) action of testosterone (DHT), which is a key driver of acne lesions.
laboratory studies have shown that clascoterone inhibits lipid production in oil-producing cells (sebcyte) and reduces inflammatory cytokines and media affected by androgens.
, the path pathages that promote acne lesions are destroyed by clascoterone.
data from two key Phase III clinical trials show that clascoterone 1% emulsions show highly statistically significant improvements at all major clinical endpoints, demonstrating successful treatment of acne and reduction of acne lesions, and good tolerance when used twice a day.
most common local skin reactions are mild erythema.
adverse events associated with treatment were not recorded during the trial period, and local skin reactions, if any, were similar to estration agents, mainly mild.
the drug was confirmed in an open-label safety study that expanded the surface area of the drug's application, including the face and torso.
prolonged local drug use and coverage did not increase the rate of significant side effects.
, chief executive of Cassiopea, said: "This landmark approval marks the introduction of a new class of topical drugs in dermatology.
dermatologist says the "holy grail" for acne treatment for men and women is the androgen hormone activity that targets the skin.
we are proud to bring this new innovation to acne sufferers.
this approval rewarded years of hard work and made Cassiopea a leader in dermatology.
now, we look forward to expanding our franchise and advancing our next research candidate for androgen baldness.
" () Origin: CASSIOPEA RECEIVES FDA AppROVAL FOR WINLEVI? (CLASCOTERONE CREAM 1%), FIRST-IN-CLASS TOPICAL ACNE TREATMENT TARGETING THE ANDROGEN RECEPTOR.