What is Clascoterone, this innovative treatment that is long overdue in Europe?

“The really promising thing about Clascoterone is that it acts on the hormonal causes of acne via a completely new mechanism,” summarizes the American dermatologist John Barbieri.

hormonal effect

Since the end of 2021, American doctors have been allowed to prescribe this cream for acne, a skin disease that is very rarely avoided over the course of a lifetime. Acne, oily skin and pimples affect around three out of four teenagers. Many adults are also affected. In the face of such a widespread disease, therapeutic innovations are rare, although research has recently made progress at other levels, such as the effects of diet.

Before the appearance of Clascoterone, anti-acne treatments had not seen any novelty for almost 40 years. Topical treatments used to fall into two broad categories: those that eliminate the acne-causing bacteria with antibiotics, and those that limit the buildup of dead cells, a process that promotes inflammation.

Clascoterone makes skin cells less sensitive to the hormones that cause sebum, the fatty substance that acne sufferers produce in excess. Other treatments that are taken orally also work at the hormone level. But these are usually birth control pills, so they are only given to women. And by directly affecting the production of hormones, they cause much more upheaval in the body.

new Hope

However, a new mechanism of action by no means guarantees the benefit of a drug; it also has to prove that it works. Such is the case with Clacosterone, which was found to be more effective than a blinded placebo and without significant side effects in a 2020 study published in Jama Dermatology. This study was conclusive enough for American authorities to approve the treatment.

But don’t expect a miracle cure or an acne revolution either. The study “isn’t comparable to existing treatments, so we don’t really know how to categorize all of this,” says French dermatologist Emilie Sbidian. However, she thinks this new drug is “very interesting” because it could give new hope to patients who are resistant to other treatments, or even be given alongside them to increase their effectiveness.

Still not in Europe

However, it is not on the agenda in Europe, where there is no indication of when the treatment will be available. Reluctance of the health authorities? Not even: The European Medicines Agency (EMA) said it had not yet started evaluating the drug.

The answer lies in the decisions of the company that makes the drug, Swiss Cosmo Pharma. “As we are a very small group, we initially focused on approval in the world’s largest market, the United States,” where the treatment is now distributed by another company, Sun Pharma, said Diana Harbort, responsible for the dermatology Unity of Cosmo.

In her opinion, the dermatology market does not interest pharmaceutical giants such as the American Pfizer and the French Sanofi, and Cosmo has to find a different partner for each region of the world. He has just succeeded in doing this in China, which he announced at the end of July as part of his quarterly results. But nothing new in Europe.

“I think there were mistakes in the group strategy”

Why does it take so long to find a partner? The group evokes a market that has long been slowed down by the Covid crisis, but this explanation does not convince all observers. “The dermatology market is pretty lively,” notes financial analyst Jamila El Bougrini. “I think there were mistakes in group strategy. »

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