Ube Industries Announces Supplemental Application in Japan Submitted for Approval of Partial Changes Related to Additional Indication for the Prasugrel Hydrochloride Antiplatelet Agent

December 15, 2020

TOKYO, December 15, 2020 — Ube Industries, Ltd. announced today that its joint research partner Daiichi Sankyo Co., Ltd. filed a supplemental application for the antiplatelet agent prasugrel hydrochloride (hereafter, prasugrel) in Japan to expand the indication for prevention of recurrence of ischemic stroke as a partial change in items of the pharmaceutical manufacturing and marketing approval for prasugrel. Prasugrel was discovered in joint research and development conducted by Ube Industries and Daiichi Sankyo.

This application is based on the results of a phase 3 study in thrombotic stroke patients in Japan (PRASTRO-III study), as well as other phase 3 studies in Japan targeting patients with ischemic cerebrovascular disease (PRASTRO-I and PRASTRO-II studies).

Ube Industries and Daiichi Sankyo are committed to providing new treatment options for ischemic stroke patients.

About prasugrel

Prasugrel is an oral antiplatelet agent discovered by Daiichi Sankyo and Ube Industries. Clinical trials in Japan and other countries have confirmed prasugrel 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, prasugrel has been co-developed by Daiichi Sankyo and Ube Industries and was approved as a treatment for ischemic heart disease patients in March 2014 with the product name Efient®. Outside of Japan, prasugrel 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).

About Ube Industries, Ltd.

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.

About ischemic cerebrovascular disease and thrombotic stroke

Ischemic cerebrovascular disease, or ischemic stroke, occurs when blood flow in the brain is somehow blocked, causing damage to brain tissue.
There are several types of ischemic cerebrovascular disease (ischemic stroke). Thrombotic stroke is one of them, and is a type of stroke that occurs due to occlusion of cerebral blood vessels by platelet thrombi, which build up mainly as a result of atherosclerosis.

The PRASTRO-I study

A study conducted in 3,747 patients with ischemic cerebrovascular disease (excluding those with cardiogenic cerebral embolisms) aged under 75, and with body weight over 50 kg, to verify non-inferiority in efficacy of prasugrel compared to clopidogrel.

The PRASTRO-II study

A study conducted in 654 patients with ischemic cerebrovascular disease (excluding those with cardiogenic cerebral embolisms) aged 75 and over, or with body weight under 50 kg, to evaluate safety of prasugrel compared to clopidogrel.


A double-blind comparative study conducted in 234 thrombotic stroke patients with one or more risk factors for the recurrence of stroke to examine efficacy and safety between prasugrel and clopidogrel treatment groups.


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