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Astellas files diabetes drug ipragliflozin in Japan

Its SGLT2 inhibitor could beat AZ-BMS' rival Forxiga to debut in that market

Astellas has made a bid to join the ranks of companies selling SGLT2 inhibitors for diabetes with a filing for its own candidate ipragliflozin in Japan. 

SGLT2 (sodium-glucose con-transporter-2) inhibitors work independently of insulin to help remove excess glucose from the body - a unique mechanism among oral antidabetic (OAD) drugs - flushing glucose from the body in the urine.

Analysts have suggested that the SGLT-2 inhibitors could become blockbuster medicines thanks to the increasing incidence of diabetes around the world and the fact that they can be used even in patients with dramatically reduced insulin function.

Last November, AstraZeneca and Bristol-Myers Squibb's Forxiga (dapagliflozin) became the first member of the new class to win approval anywhere in the world, getting a green light in the EU as a once-daily treatment for adults with type 2 diabetes although it has suffered some delays in the US. 

Ipragliflozin (formerly ASP1941) has been filed in Japan on the back of phase III trials which showed that it could provide significant reductions in glycated haemoglobin levels (HbA1c) levels - a marker of glucose control over time - compared to placebo. 

Astellas' drug also was shown to be safe and effective when used in combination with other OADs, increasing glucose control whilst also achieving significant reductions in body weight. Ipragliflozin is being co-developed with Kotobuki Pharmaceutical, said Astellas.

Other companies developing SGLT2 inhibitors include Johnson & Johnson, whose Invokana (canagliflozin) was filed for approval in the US last summer and was backed by an FDA advisory committee in January - and Boehringer Ingelheim/Eli Lilly's empagliflozin which is scheduled for regulatory submissions during 2013.

According to Astellas' latest R&D pipeline update in February 2013, Astellas is developing ipragliflozin only in Japan. The same document in August 2012 indicated it was also carrying out phase II studies with the drug in the US and Japan.

- Meanwhile, Astellas said it has ended its collaboration with Ambit Biosciences of the US on the development of FMS-like tyrosine kinase-3 (FLT3) inhibitors, including lead acute myeloid leukaemia candidate quizartinib (AC220) which had reached phase IIb testing. The Japanese pharma company said it had taken the decision for "strategic reasons".

14th March 2013

From: Sales



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