Indian drugmaker Orchid Pharma's antibiotic drug Exblifep (cefepime/enmetazobactam) has received approval from the European Medicines Agency (EMA), leading to a 20% surge in the company's stock.
The EMA granted marketing authorization for the drug indicated for the treatment of complex urinary tract infections, pneumonia, and bacteremia caused by ESBL-producing pathogens.
The company said in a filing that the primary novel component, enmetazobactam, is the first drug invented in India to secure EMA approval.
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