TOKYO, December 24, 2021 —Ube Industries, Ltd. (hereinafter Ube Industries) announced today that its joint research and development partner Daiichi Sankyo Co.,(hereinafter Daiichi Sankyo) 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 was discovered in joint research and development conducted by Ube Industries and Daiichi Sankyo, 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).
By delivering a new option for the treatment of ischemic cerebrovascular diseases, Ube Industries and Daiichi Sankyo hope to contribute to the healthcare of patients.
Efient® is an oral antiplatelet agent discovered by Daiichi Sankyo and Ube Industries. Clinical trials in Japan and other countries have confirmed Efient®to have a stable antiplatelet effect for the duration of the treatment time and excellent effectiveness in reducing risk of cardiovascular events in ischemic heart disease patients undergoing percutaneous coronary intervention (PCI).
In Japan, Efient®has been co-developed by Daiichi Sankyo and Ube Industries and was approved as a treatment for ischemic heart disease patients in March 2014. Outside of Japan, Efient® was granted marketing authorization in Europe and the United States in 2009 for prevention of atherothrombotic events in patients with acute coronary syndrome undergoing PCI, and has now been launched in countries around the world (with the product names Efient® or Effient® in Europe, the United States, and other countries).
Ube Industries (Head office: Ube City, Yamaguchi Prefecture; President: Masato Izumihara) is a chemistry-focused company that is also engaged in the construction materials and machinery businesses. In its pharmaceutical business, Ube Industries aims to contribute to better health for everyone with community-based manufacturing of drugs using innovative technologies. Going forward, Ube Industries will continue creating promising new compounds for new medicines with a dual approach of pursuing drug discovery through internal and joint research and development projects, and manufacturing and supply of APIs and intermediates.
|Generic Name||Prasugrel hydrochloride|
(underline: additional indication)
|Dosage and Administration
(underline: additional dosage and administration)
|Date of Partial Change Approval||December 24, 2021|
|Manufacturing and Marketing||Daiichi Sankyo Company, Limited|
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.
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.
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.