Health. Acne: European green light for a new treatment for adolescents

The European Medicines Agency (EMA) issued a favorable opinion on August 25 for the granting of a marketing authorization for the drug Winlevi, a treatment for facial acne. in adults and teenagers (from 12 years old).

This one is already available in the United States, Canada, the United Kingdom, Australia, Malaysia, and Singapore. To understand how it works, you first need to understand how it works. acne.

What are the mechanisms of acne?

Sebum is an oily substance produced by the sebaceous glands located in hair follicles.

Normally secreted to protect the skin from drying out and external aggressions, sebum, in the case of acne, is secreted excessively under the action of androgen hormones, at the time of puberty or at certain times of the menstrual cycle.

Excessive sebum secretion combined with thickening of the hair follicle causes seborrheic retention which manifests itself through the appearance of blackheads and whiteheads.

Inflammation may eventually occur due to damage caused by excess sebum in the follicle but also due to the proliferation of the microorganism Cutibacterium Acnes.

This feeds on sebum and proliferates when its food proliferates. The inflammatory lesions of acne then form: superficial, papules and pustules, or deep (superinfected by other bacteria present on the skin), nodules and cysts.

An innovative mode of action

Winlevi is a cream whose active ingredient is clascoterone. This is an inhibitor of androgen receptors, the male hormone.

Clascoterone has thus shown its ability to counter the effects of androgens, which boost sebum production in the sebaceous glands.

Results: A reduction in sebum production and the accumulation of inflammatory mediators known in acne.

An innovative treatment because standard acne treatments exfoliate dead cells from the pores, which promote inflammation, or neutralize the bacteria responsible for acne with antibiotics.

A re-examination and a thorough clinical evaluation

This was actually a re-examination after a negative opinion initially issued by the EMA. The drug had been approved for adults, but the European health authority had judged the benefit/risk in adolescents to be negative.

Cosmo, the manufacturer, then launched a more in-depth clinical evaluation and obtained a positive opinion from the EMA for the use of Winlevi in ​​12- to 18-year-olds.

"It's a real step forward," said Professor Brigitte Dréno, founding member of the European Association of Dermato-Oncology, former president of the French Society of Dermatology and member of the American Academy of Dermatology, quoted in the Cosmo press release.

"We've been waiting for an innovation like this: a topical antiandrogen that's well-tolerated, effective, and safe for adolescents. It will be a valuable addition to our treatment options."

To see Winlevi marketed in France, we will still have to wait for a positive opinion from the High Authority of Health.

Source : Cosmo, EMA, Vidal.fr