Astellas Pharma Inc.
) 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
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
Lannett Company, Inc.
WuXi Pharma Tech (Cayman) Inc.
) look more attractive. All three stocks carry a Zacks Rank #1
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