EMA/CHMP recommends empagliflozin for approval for type 2 diabetes

German family-owned drug major Boehringer Ingelheim and partner Eli Lilly (NYSE: LLY) of the USA have announce a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of the investigational sodium glucose co-transporter 2 (SGLT2) inhibitor empagliflozin.

If approved, the drug will be marketed under the name Jardiance for the treatment of adults with type 2 diabetes (T2D). The latest news is a positive for the companies, given that the US Food and Drug Administration recently declined approval of empagliflozin, issuing a complete response letter referencing previously-observed deficiencies at a Boehringer Ingelheim facility where the drug will be manufactured (The Pharma Letter March 5).

Empagliflozin is an investigational compound that belongs to the SGLT2 inhibitor class of drugs that targets glucose directly and works independently of beta-cell function and insulin resistance. Following the CHMP positive opinion, the European Commission generally follows the recommendation and usually issues its final decision for marketing authorization within two months.