Savara Says FDA Has No Plans for Advisory Meeting for Lung Disease Treatment Application

By Kelly Cloonan

Savara said the Food and Drug Administration does not plan to convene an advisory committee to review its biologics license application for a potential lung disease treatment.

The biopharmaceutical company said Friday the FDA's review of its application for Molbreevi is ongoing, targeting a Prescription Drug User Fee Act action date of Aug. 22.

The company also said it submitted a marketing authorization application to the European Medicines Agency, and its submission to the U.K. Medicines and Healthcare Products Regulatory Agency remains on track by the end of the first quarter.

Molbreevi was previously granted fast track, breakthrough therapy and orphan drug designations by the FDA. It aims to treat autoimmune pulmonary alveolar proteinosis, a rare lung disease.

Write to Kelly Cloonan at [e-mail]

(END) Dow Jones Newswires

03-06-26 1645ET