The European Medicines Agency has accepted a marketing authorization application for Paratek Pharmaceuticals Inc.'s Nuzyra to treat a type of bacterial pneumonia and a certain skin infection.
Nuzyra, or omadacycline, was approved by the U.S. Food and Drug Administration earlier in October to treat adult patients with community-acquired bacterial pneumonia and acute skin and skin structure infections.
The marketing authorization application is supported by multiple phase 3 studies for Nuzyra, which show that the drug meets all endpoint requirements of EMA.