Merck (MRK) said Wednesday that the European Commission has approved its drug Capvaxive for immunization against invasive disease and pneumonia caused by streptococcus in people aged 18 years or older.
The specific indication for the drug applies to 22 streptococcus pneumoniae serotypes responsible for the majority of invasive pneumococcal disease cases, the company said.
The approval is based on safety and efficacy data from two phase 3 clinical trials and follows a positive recommendation in January from the European Medicines Agency's Committee for Medicinal Products for Human Use, the company said.
The drug was approved in the US and Canada last year and in Australia in January, the company said.
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