Yesterday, the United States Food and Drug Administration (FDA) approved a new player in the acne world: Winlevi (clascoterone cream 1%) for the treatment of acne in men and women over the age of 12.
According to a release from Cassiopea, the pharmaceutical company responsible for developing and commercializing this drug, “acne is the most prevalent skin condition in the U.S. affecting up to 50 million Americans annually,” making it apparent that finding a cure for this skin condition is much harder than we think.
“The last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago,” says the release. It was one of the strongest cures for acne ever developed, also known as Accutane (isotretinoin).
The biggest difference with Winlevi is that it’s a topical cream, making it a little less intimidating than having to swallow a pill like Accutane or birth control (which is often used for targeting acne in women). But unlike other topicals like retinoids, Winlevi is the first to use a brand new active ingredient: 1% clascoterone, which targets androgen receptors—responsible for sebum buildup and inflammation—in the skin.
“In the same way that certain birth control pills (Yaz) act as systemic anti-androgens, clascoterone, the active ingredient in Winlevi, acts as a topical anti-androgen,” says Spokane, WA dermatologist Wm. Philip Werschler, MD, who was one of the clinical investigators for the FDA trials for Cassiopea. “This bypasses the systemic effects and also allows use in men.”
“There is consensus amongst dermatologists that one of the four causes of common acne vulgaris (adolescent acne) is the surge of androgens during puberty that over stimulate the pilosebaceous units (oil gland hair follicle complex),” Dr. Werschler explains. This cream could put an end to the grueling struggle of hormonal acne, ridding the chances of dealing with this skin condition early on.
Despite the use for adolescents, Dr. Werschler suspects that Winlevi will be used in combination with other topicals, and in some cases with systemic therapy (i.e. antibiotics) for more severe cases at any age.
But the push for a wider variety of acne treatments isn’t over: “Winlevi is just one of a bevy of new acne products that are already approved or expected to be FDA approved in the coming months. Some of these include Arazlo, Seysara and Amzeeq,” he says.
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