A new treatment is overdue in Europe

A new treatment is overdue in Europe

After several decades, this is the first real breakthrough against acne. Clascoterone, a promising treatment, has been prescribed for several months in the United States but, in Europe, it is not known when this drug will be available.

“What is the real promise of clascoterone is that it works through a completely new mechanism of (causes) hormonal acne,” summarized the American dermatologist John Barbieri to AFP.

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 a person’s life. Acne, oily skin and acne affect about three out of four teenagers. Many adults are also affected.

Nothing new in 40 years

Faced with such a widespread disease, therapeutic changes are rare, although research has recently progressed on other levels such as the effects of food. Before the appearance of clascoterone, anti-acne treatments did not register anything new for almost 40 years.

Topical treatments used to be divided into two broad categories: those that eliminate acne-causing bacteria using 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 excess. Some treatments, taken orally, also act on hormonal levels. But these are usually birth control pills, so they are exclusively given to women. And, by directly influencing the production of hormones, it causes more serious disorders in the body.

Not a miracle cure

However, a new mechanism of action is far from ensuring the interest of a drug, it is also necessary to 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 cure or an acne revolution.

The study “does not compare with existing treatments, so we do not know very well how to put all that,” French dermatologist Emilie Sbidian said to AFP. However, he considers this new drug “very exciting” because it may give new hope to patients who are reluctant to other treatments, or even given in addition to them to increase their effectiveness. .

Pharmaceutical giants are not interested in dermatology

However it is not on the agenda in Europe, where there is no indication of when the treatment will be available. Denial of health authorities? Not even: the European Medicines Authority (EMA) told AFP that it has not yet begun to evaluate the drug.

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

According to Ms. Harbort, the dermatology market is not interested in pharmaceutical giants, such as the American Pfizer and the French Sanofi, and Cosmo must find a different partner for each region of the world.

This was recently achieved in China, which announced at the end of July its quarterly results. But, in Europe, nothing new.

Strategic mistake?

Why does it take so long to find a partner? The group evoked a market that had been slowed for a long time by the Covid-19 crisis, but this explanation did not convince all observers. “The dermatological market is very strong,” said financial analyst Jamila El Bougrini to AFP. “I think there are mistakes in the strategy of the group. »

The analyst, who does not understand why no evaluation has been launched with the European authorities, particularly evokes an unfortunate choice of Cosmo in recent years: the group wants to sell its dermatology division, where the clascoterone is the only product, before giving it. because there is a lack of buyers.

“Aren’t they very selfish?” asked Ms. El Bougrini, who finds it difficult to interest investors if a treatment does not appear to be more effective than existing drugs.

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