Molgramostim BLA review period extended

What this means

Molgramostim is an inhaled immune-stimulating protein that helps clear lung buildup in autoimmune pulmonary alveolar proteinosis, a rare condition where the immune system fails to remove debris from air sacs. The FDA extended its review deadline for Savara's application by three months to allow more time to evaluate the data. This delay pushes the potential approval decision to later in 2024, leaving patients waiting longer for what could be the first FDA-approved treatment specifically for this disease.