what is clascoterone, this innovative treatment that is long overdue in Europe?

“What is really promising with clascoterone is that it acts by a completely new mechanism on the hormonal causes of acne”, summarizes the American dermatologist John Barbieri.

Hormonal action

Since the end of 2021, American doctors have been able to prescribe this cream against acne, a skin disease from which it is very rare to escape during one’s life. Acne, oily skin and pimples affect about three out of four teenagers. Many adults are also affected. Faced with such a widespread disease, therapeutic innovations are rare, although research has recently progressed on other levels such as the effects of diet.

Before the appearance of clascoterone, anti-acne treatments had not registered any novelty for almost 40 years. Topical treatments were previously divided into two broad categories: those that eliminate the bacteria causing acne with antibiotics, and those that limit the accumulation of dead cells, a process that promotes inflammation.

Clascoterone makes skin cells less receptive to the hormones that cause sebum, the fatty substance that acne sufferers produce in excessive quantities. Other treatments, taken orally, also act on the hormonal level. But these are usually birth control pills, so exclusively given to women. And, by directly influencing the production of hormones, they cause much heavier upheavals in the body.

new hope

However, a new mechanism of action is far from ensuring the interest of a drug, it must also prove that it works. This is the case of clacosterone, which a study, published in 2020 in Jama Dermatology, found to be more effective than a placebo given blindly, and without significant side effects. This study was conclusive enough for the American authorities to approve the treatment.

But don’t expect a miracle drug or an acne revolution either. The study “does not compare with existing treatments, so we don’t really know how to place all that,” tempers French dermatologist Emilie Sbidian. However, she considers this new drug “very interesting” because it could offer new hope to patients reluctant to other treatments, or even be given in addition to them to increase their effectiveness.

Still not in Europe

Yet it is not on the agenda in Europe, where there is no indication when the treatment will be available. Reluctance of health authorities? Not even: the European Medicines Authority (EMA) indicated that it had not started to evaluate the drug.

The answer is to be found in the choices of the company that produces the drug, the Swiss Cosmo Pharma. “As we are a very small group, we first focused on authorization in the world’s largest market, the United States” where the treatment is now distributed by another company, Sun Pharma, explained Diana Harbort, responsible for of Cosmo’s dermatology unit.

According to her, the dermatology market does not interest the pharmaceutical giants, such as the American Pfizer and the French Sanofi, and Cosmo must find a different partner for each region of the world. It has just achieved this in China, which it announced at the end of July during its quarterly results. But, in Europe, nothing new.

“I think there were group strategy errors”

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

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