BioCentury
ARTICLE | Clinical News

Scenesse afamelanotide: Phase II started

June 9, 2014 7:00 AM UTC

Clinuvel began the double-blind, placebo-controlled, Singaporean Phase II CUV103 trial to compare 16 mg Scenesse every 4 weeks plus twice-weekly narrow-band ultraviolet B (NB-UVB) light vs. NB-UVB light alone for 7 months in about 60 patients with nonsegmental vitiligo. An MAA for Scenesse is under EMA review for prophylactic treatment of erythropoietic protoporphyria (EPP), with a decision expected mid-2014. Earlier this year, Clinuvel said EMA extended the review period to allow the review of data from the U.S. Phase III CUV039 trial (see BioCentury, Feb. 3). ...