EMA's CHMP recommends approval of Glyxambi (empagliflozin and linagliptin) for type 2 diabetes- Boehringer

The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Glyxambi (empagliflozin and linagliptin), from Boehringer, intended for the treatment of type 2 diabetes mellitus. Glyxambi will be available as film-coated tablets (containing either 10 mg empagliflozin and 5 mg linagliptin, or 25 mg empagliflozin and 5 mg linagliptin).

In Phase III trials it was found that the benefit with Glyxambi is its ability to lower blood glucose. The most common side effect was urinary tract infection (7.5% with Glyxambi 10 mg/5 mg and 8.5% with Glyxambi 25 mg/5 mg). The most serious adverse reactions were ketoacidosis (less than 0.1%), pancreatitis (0.2%), hypersensitivity (0.6%), and hypoglycaemia (2.4%).