Savara Receives Breakthrough Therapy Designation for Molgradex

The FDA granted breakthrough therapy designation to Savara’s Molgradex for the treatment of autoimmune pulmonary alveolar proteinosis.

The designation was granted based on results from a phase 3 clinical study that found the drug to be safe and effective based on changes in lung pathology, physiology, health status, function, and the systemic response.

The new designation “reflects the significance of Molgradex as an investigational product that, based on the IMPALA study, has been demonstrated to improve patient outcomes,” said Savara CEO Rob Neville.