Daiichi Sankyo gets approval for additional indication of Antiplatelet Agent Efient in Japan

Tokyo: Daiichi Sankyo Company, Limited has announced that the company has obtained a supplemental new drug application approval for additional indication and dosage and administration of the antiplatelet agents "Efient 3.75 mg Tablets" and "Efient 2.5 mg Tablets" (generic name prasugrel hydrochloride, hereinafter "Efient Tablets") in Japan.

This approval authorizes Efient Tablets to be used for "Prevention of recurrence of ischemic cerebrovascular disease following the former appearance of ischemic cerebrovascular disease (associated with large-artery atherosclerosis or small-vessel occlusion) (restricted to cases with a high risk of ischemic stroke)."

In December 2020, Daiichi Sankyo submitted an application for the partial change approval in approved items for drug marketing of Efient Tablets based on results from a phase 3 study in thrombotic stroke patients in Japan (PRASTRO-III study) and other phase 3 studies in Japan targeting patients with ischemic cerebrovascular disease (PRASTRO-I and PRASTRO-II studies). 

PRASTRO-I study

This study verified the non-inferiority in the efficacy of prasugrel hydrochloride to clopidogrel in 3,747 patients with ischemic cerebrovascular disease (excluding those with cardioembolic stroke) younger than 75 years and weighing more than 50 kg.

PRASTRO-II study

This study evaluated the safety of prasugrel hydrochloride in 654 patients with ischemic cerebrovascular disease (excluding those with cardioembolic stroke) aged 75 years or older and weighing 50 kg or less using clopidogrel as the control.

PRASTRO-III study

This study compared the efficacy and safety of prasugrel hydrochloride and clopidogrel in 234 patients with thrombotic stroke and at least one risk factor for the recurrence of ischemic stroke.

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