EMA Accepts Marketing Authorization App for Boehringer, Lilly Empagliflozin

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Boehringer Ingelheim and Eli Lilly and Company
LLY
today announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin*, for the treatment of type 2 diabetes mellitus (T2D) in adults. The acceptance of the MAA marks the beginning of the review process in the European Union for this potential oral diabetes treatment. "We are pleased the EMA has accepted our marketing authorization application for a potential new treatment option to help patients better manage their type 2 diabetes mellitus," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "More than 300 million people worldwide live with type 2 diabetes mellitus and varied approaches to treating this condition are needed to help these patients better manage their condition." A New Drug Application for empagliflozin was recently submitted to the Food and Drug Administration (FDA) in the United States for the treatment of T2D in adults. Empagliflozin is a member of the SGLT2 inhibitor class of drugs being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.
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