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Takeda Seeks Japanese Approval

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Takeda Pharmaceutical Company Limited recently announced the submission of a new drug application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for its drug Takepron (lansoprazole). The company is seeking approval of a fixed-dose combination of Takepron and low-dose aspirin for treating patients suffering from peptic ulcer.

Patients taking low-dose aspirin to prevent recurrence of cerebral infarction or myocardial infarction are on the rise with Japan’s aging population. We note that the administration of low-dose aspirin may cause disorders such as gastric and duodenal ulcer. Therefore, it becomes very important to prevent the onset of ulcers in the said population group.

Takeda filed the NDA on the basis of a study of bioequivalence between the fixed-dose combination therapy and two pills of Takepron and low-dose aspirin.

We note that Takepron, a proton pump inhibitor, is already approved for the prevention of recurrence of ulcers in patients requiring administration of low-dose aspirin for a long period. The patients have a history of gastric and duodenal ulcer.

We remind investors that a few days back Takeda submitted an NDA for Adcetris (brentuximab vedotin) in Japan for the treatment of adults suffering from relapsed or refractory CD30 positive Hodgkin lymphoma (HL) and relapsed or refractory CD30 positive anaplastic large cell lymphoma (ALCL).

Currently Takeda carries a Zacks Rank #4 (Sell). Comparatively, Lannett Company, Inc. (LCI - Free Report) , UCB SA (UCBJF - Free Report) and Cytokinetics, Inc. (CYTK - Free Report) look better-positioned in the pharma space. They all carry a Zacks Rank #1 (Strong Buy).

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