European regulators have accepted an application from Paratek Pharmaceuticals seeking approval of the broad-spectrum antibiotic omadacycline for two types of infection.
The group wants permission to market the drug – a modernised tetracycline – for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
The application contains data from a Phase III programme which included three pivotal registration studies supporting approval, in omadacycline “met all required EMA primary endpoints” and also “demonstrated a generally safe and well-tolerated profile,” according to the firm.
The drug, which comes in both oral and intravenous formulations, was recently approved in the US under the trade name Nuzyra.
“Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalisations and the costs associated with hospital stays,” said Paratek’s president, chief operating officer, and chief medical officer, Evan Loh, commenting on the US approval.
“Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients,” added Keith Kaye, director of Clinical Research, Division of Infectious Diseases, University of Michigan.
“There continues to be a need for novel antibiotics with both IV and oral formulations, such as Nuzyra, to help physicians stay ahead of the evolving resistance landscape.”
A decision from the European Medicines Agency is expected in the second half of next year, the firm said.
