Biotech Daily Dose

Cosmo Pharma Gets Regulatory Approval For Acne Treatment Winlevi In South Korea

Cosmo Pharmaceuticals N.V. (COPN.SW), an Irish life sciences company focused on MedTech AI dermatology and gastrointestinal diseases, on Tuesday announced that the Ministry of Food and Drug Safety of the Republic of Korea has approved Winlevi, also known as clascoterone cream 1% for the treatment of acne vulgaris in patients aged twelve years and older.

As per a license agreement signed in June 2023, Cosmo Pharma granted Hyundai Pharm Co., Ltd. exclusive rights to register and commercialize Winlevi in South Korea.

Currently, in addition to South Korea, Winlevi is approved in ten more countries, including the United States, Canada, Australia, the United Kingdom, New Zealand, Singapore, and Malaysia. Winlevi was approved in the United States for the treatment of acne in August 2020.

Acne vulgaris is among the most common skin conditions worldwide, affecting over 90 percent of people at some point in their lives. Other alternative drugs used for treating acne globally include Spironolactone and Doxycycline.

Giovanni Di Napoli, CEO of Cosmo Pharmaceuticals, said," Approval of Winlevi in South Korea is a meaningful milestone in our dermatology global expansion and further evidence that we are executing against our 2030 Vision by driving sustainable growth through innovation and focused geographic scale-up".

On Thursday, in the Swiss market, the shares were trading 0.59% at 68.40 Swiss Francs.

by RTTNews Staff Writer

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