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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval to Boehringer Ingelheim and Eli Lilly's investigational sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin for the treatment of adults with Type 2 Diabetes (T2D).
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The company said that if approved, empagliflozin will be marketed under the name Jardiance.
Empagliflozin belongs to the SGLT2 inhibitor class of drugs that targets glucose directly and works independently of ß-cell function and insulin resistance.
The CHMP positive opinion is based on results from one of the largest clinical registration programs in its class, comprised of over ten multinational clinical trials and more than 13,000 adults with T2D.
After the positive opinion, the European Commission (EC) generally follows the recommendation and usually issues its final decision for marketing authorization within two months.
Boehringer Ingelheim corporate senior vice president Medicine Klaus Dugi said the CHMP positive opinion brings the company a step closer to having a potential new treatment option in Europe for people with Type 2 Diabetes.
"If approved, empagliflozin would be the third product approved in Europe as part of the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance," Dugi said.