Allecra Therapeutics gets US FDA approval for Exblifep

The US Food and Drug Administration (FDA) has approved the marketing application for Exblifep (cefepime/enmetazobactam), submitted by Franco-German firm Allecra Therapeutics, as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.

Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act). The GAIN Act, enacted by the US Congress, incentivizes the creation of new anti-infective therapeutics by providing benefits to manufacturers of Qualified Infectious Disease Products (QIDPs).

Last month, Exblifep received approval from the European Medicines Agency (EMA) for the treatment of complex urinary tract infections, pneumonia, and bacteremia caused by ESBL-producing pathogens.