Clinuvel cinches FDA nod for rare skin disease drug

Oct. 9, 2019

For the first time ever, patients in the U.S. with a rare but painful skin disease will have access to an FDA-approved treatment.

This week, Australia-based Clinuvel Pharmaceuticals announced that the FDA has approved Scenesse, its treatment for erythropoietic protoporphyria (EPP), an inherited disorder that can cause skin to itch, burn or scar when exposed to light. An estimated 75,000 to 200,000 people are affected by the disease worldwide.

Scenesse, an under-the-skin implant, was already approved for use in Europe in 2014. Clinuvel is also investigating the use of Scenesse for other diseases such as pigmentation disorder vitiligo.

Read the Reuters report.