The Committee for Medicinal Products for Human Use (CHMP) positive opinion is now referred for final action to the European Commission, which grants approval in the EU.
The commission usually makes a decision about whether to approve a new drug candidate within two to three months of CHMP issuing its recommendation. Upon approval, this new oral antiplatelet agent is expected to be marketed throughout the EU under the proposed brand name Efient.
John Alexander, global head of R&D at Daiichi Sankyo Company, said: “We are extremely pleased by the CHMP positive recommendation for approval of prasugrel in Europe. Based on the study results and the positive recommendation, we are hopeful that prasugrel will be approved as a new treatment option for patients with acute coronary syndromes undergoing percutaneous coronary intervention.”