The Food and Drug Administration has rejected an application filed by Langhorne-based Savara for its new drug candidate Molbreevi as a treatment for rare lung disease, autoimmune pulmonary alveolar proteinosis, writes John George for the Philadelphia Business Journal.
The FDA stated in a “refusal to file letter” that a preliminary review determined the biopharmaceutical company’s application was not sufficiently completed to allow for substantive review. The federal agency requested more data on the drug candidate’s chemistry, manufacturing, and controls.
Savara said the decision was not related to safety concerns and the agency did not ask for additional efficacy studies for Molbreevi.
The company will request a meeting within the next 30 days to discuss the additional data requested.
“We look forward to meeting with the FDA to align on next steps,” said Matt Pauls, CEO of Savara.
Pauls added Savara is confident it can “thoroughly address” the request made by the FDA.
The company is also working on establishing a redundant supply chain and is on track to finalize a technology transfer with the contract manufacturer for its second-source drug substance in the fall.
Following Tuesday’s decision by the agency, the Bucks County company saw its stock price drop 30 percent.
For a closer look at what this setback means for Savara’s future—and how the company plans to bounce back—read the full story with exclusive insights on the Philadelphia Business Journal website.
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