Astellas Pharma Inc. (ALPMY) recently announced the submission of a marketing authorization application (MAA) for its sodium-glucose co-transporter 2 (SGLT2) inhibitor, ipragliflozin (ASP1941), to the Ministry of Health, Labour and Welfare (MHLW) in Japan. Astellas is looking to get ipragliflozin approved for the treatment of type II diabetes. Astellas and Kotobuki Pharmaceutical Co., Ltd have a research collaboration for ipragliflozin.
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.
On Oct 2, 2012, Astellas had presented results from two Japanese phase III studies conducted on ipragliflozin in combination with other hypoglycemic agents at the annual meeting of the European Association for the Study of Diabetes.
These studies showed a statistically significant reduction in HbA1c compared to baseline and against placebo of up to 1.14% in the Sulfonylurea (SU) study and up to 0.88% in the Pioglitazone (PIO) study. The SU and PIO studies showed statistically significant reduction in body weight of up to 1.32 kg and 2.79 kg, respectively.
The approval of ipragliflozin in Japan will enhance Astellas’ portfolio. Another diabetes candidate in the company's pipeline is PSN821. Meanwhile, we note that other companies are also developing SGLT2 inhibitors. SGLT2 inhibitors currently in development include canagliflozin and LX4211.
Astellas carries a Zacks Rank #4 (Sell). Currently, companies like Lannett Company, Inc. (LCI - Snapshot Report), WuXi Pharma Tech (Cayman) Inc. (WX - Snapshot Report) and QLT Inc. (QLTI - Analyst Report) look more attractive. All three stocks carry a Zacks Rank #1 (Strong Buy).