July 15 Quick Takes: Early access in U.K. for Alnylam RNAi; plus Verrica, CytoDyn, J&J and Roche

U.K. clears early access to lumasiran
The U.K.’s Medicines and Healthcare products Regulatory Agency is making lumasiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) available to patients with primary hyperoxaluria type I before its approval by the EU. A decision on the RNAi therapy targeting HAO1 by the European Commission, which will apply to the U.K., is expected late this year. The therapy is under FDA Priority Review with a Dec. 3 PDUFA date. The MHRA’s decision comes via the Early Access to Medicines Scheme (EAMS).

FDA rebuffs Verrica’s molluscum treatment
Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) said it received a complete response letter from FDA for VP-102, its drug-device combination to treat molluscum contagiosum. The agency is seeking additional CMC information, but did not identify any clinical deficiencies, according to the company. VP-102 is a topical film forming solution of cantharidin administered through a single-use applicator...