Astellas Pharma, Inc.
) 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
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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
Lannett Company, Inc.
WuXi Pharma Tech (Cayman) Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).