Differin maker Galderma wins FDA approval for a new retinoid for acne
Data suggest that in 2016 the burden of acne vulgaris — the chronic inflammatory skin disease — ballooned to roughly $3 billion in healthcare costs and lost productivity in the United States. Now those pesky blemishes have a new foe in the form of a topical retinoid from Galderma.
Galderma on Friday said it had secured the approval of trifarotene, a topical retinoid cream. Retinoids are a class of medications derived from vitamin A that have long played in key role in acne therapy. Retinoids interact with retinoic acid receptor (RAR) and retinoid X receptor (RXR) — members of a superfamily of ligand-activated transcription factors — to reduce visible lesions as well as inhibit the development of microcomedones and new lesions.
The maker of Differin — a popular over-the-counter topical retinoid — will make the new treatment, christened Aklief, available in November. It is the first topical treatment specifically studied and shown to help both facial and truncal (chest, shoulders, and back) acne.
Aklief is engineered to selectively target RARγ, versus existing first- and third-generation topical retinoids, which target both RARβ and RARγ. It was tested in twin 12-week studies: PERFECT 1 and PERFECT 2 involving more than 2,400 patients between 2015 to 2017. In both anatomic regions, the product was significantly superior to the vehicle in success rates and in the reduction of inflammatory and noninflammatory lesion counts.
The importance of retinol, or vitamin A, was discovered during World War I — subsequent research showed that its deficiency gives rise to xerosis (dry skin) and follicular hyperkeratosis (keratin buildup around the hair follicles). But before the compound could enter the zeitgeist, scientists worked on synthesizing compounds similar to vitamin A with an improved safety and efficacy profile — and these were eventually introduced for the treatment of dermatoses.
Five years after the Swiss conglomerate Nestlé swallowed the dermatology company Galderma, it unveiled plans to exit the skin health business to return to its roots in food and nutrition. Earlier in 2019, Nestlé divulged it was in exclusive negotiations with a consortium led by EQT and a wholly owned subsidiary of the Abu Dhabi Investment Authority (ADIA) to sell Nestlé Skin Health in the region of CHF 10.2 billion (about $10.3 billion). Last week, the sale was consummated. An independent Galderma is now run by Flemming Ornskov, who led Shire before it was swallowed by Japan’s Takeda.