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Regeneron anticipates "gradual" PCSK9 launch

May 8, 2015 2:17 AM UTC

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) signaled it expects "an initial gradual uptake at launch" for Praluent alirocumab to treat high cholesterol. A BLA for the PCSK9 inhibitor from Regeneron and Sanofi (Euronext:SAN; NYSE:SNY) is under Priority Review by FDA, with a July 24 PDUFA date.

On the company's 1Q15 earnings call, CSO George Yancopoulos said Regeneron expects the reimbursement environment for PCSK9s to be "complex and carefully managed." He added, "It will likely take several months for commercial and government payers to conduct formulary reviews, make reimbursement coverage decisions, and begin to process patient claims." ...