Posted by Michael Wonder on 27 May 2025
Savara receives refusal to file letter from the US FDA for the biologics license application for Molbreevi to treat patients with auto-immune pulmonary alveolar proteinosis
27 May 2025 - Savara today announced that the Company received a refusal to file letter from the FDA for the biologics license application of Molbreevi as a therapy to treat patients with auto-immune pulmonary alveolar proteinosis.
Upon preliminary review, the FDA determined that the biologics license application submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls.
