Astellas Pharma, Inc. (ALPMY) and Zeria Pharmaceutical Co., Ltd. recently announced that it received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Acofide for the treatment of functional dyspepsia (FD).
The regulatory application was based on a multicenter, randomized, double-blind, parallel-group and placebo-controlled phase III clinical study. The results showed statistically significant data when compared to placebo, in both the primary endpoints and several secondary endpoints.
In Mar 2008, Astellas and Zeria had entered into an agreement for the co-development and co-marketing of Acofide. Zeria had submitted the application for marketing approval to the MHLW in Japan in Sep 2010.
Acofide is the first approved product to have shown efficacy for the treatment of FD under the Rome III diagnostic criteria. Rome III is the latest version of the international classification and diagnostic criteria for functional gastrointestinal disorders.
Meanwhile, Astellas is also looking to get its type II diabetes candidate, ipragliflozin (ASP1941), approved in Japan. Earlier this month, Astellas had announced the submission of a marketing authorization application (MAA) for its sodium-glucose co-transporter 2 (SGLT2) inhibitor, ipragliflozin (ASP1941), to the MHLW in Japan. The application was based on a phase III pivotal study on ipragliflozin as monotherapy for the treatment of type II diabetes. The study showed a significant reduction in HbA1c levels. Astellas conducted six phase III studies to investigate the long-term safety and efficacy of ipragliflozin in combination with other hypoglycemic agents. Results showed effectiveness and a favorable safety profile.
Astellas carries a Zacks Rank #4 (Sell). Currently, companies like Lannett Company, Inc. (LCI), UCB (UCBJF) and WuXi Pharma Tech (Cayman) Inc. (WX) look more attractive with a Zacks Rank #1 (Strong Buy).
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