Wednesday, March 13, 2013

Astellas submits application for approval to MHLW for its SGLT2 inhibitor Ipragliflozin

Ipragliflozin was discovered through research collaboration with  Kotobuki Pharmaceutical
Co., Ltd. In clinical trials Ipragliflozin has demonstrated a robust efficacy and safety 
In the ILLUMINATE study, Japanese patients inadequately controlled on metformin, 
were randomized to Ipragliflozin as add on to metformin and metformin alone arm in a
 2:1 ratio. Patients on Ipragliflozin demonstrated a HbA1C reduction of 1.29% (is better 
than cana in the same population). The rate of UTI events were lower in the Ipra arm
compared to metformin alone, suggestive of best in class safety . Genital infections 
were higher in Ipra arm, but on a relative basis, it was still lower than observed with
other SGLT2 pipeline drugs.

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