Japanese regulators approve PCSK9 drug from Sanofi, Regeneron
- Sanofi and Regeneron’s new PCSK9 cholesterol drug Praluent won marketing and manufacturing approval in Japan on Tuesday, expanding the drug’s market reach even as it struggles to gain traction in the U.S.
- Praluent has been approved for the treatment of both refractory hypercholesterolemia and familial hypercholesterolemia in Japan, based on global trials and a Phase 3 study focusing specifically on Japanese patients.
- Praluent’s approval in Japan comes nearly six months after rival Amgen’s joint venture with Astellas received approval for its PCSK9 drug, Repatha.
When Praluent was first approved in the U.S. and Europe last year, clinical data showing a 60% reduction in so-called “bad” cholesterol looked set to vault the drug to a strong launch. However, a hefty price tag of roughly $14,600 led some payers to delay full coverage for Praluent, slowing uptake and cutting into hopes of fast sales.
Data from the Phase 3 trial of Japanese patients reaffirmed results from the pivotal U.S. trials. The safety profile was consistent with the current labeling in markets where Praluent is already approved—the U.S., the E.U., Canada and Mexico.
Although Praluent has been approved by the Ministry of Health, Labor and Welfare in Japan, it still has to undergo review by the Central Social Insurance Medical Council, which determines prices.