<2> Savara Receives FDA Day 74 Letter for Autoimmune Pulmonary Alveolar Proteinosis (PAP) Drug
<3> Overview of the FDA Day 74 Letter
The FDA Day 74 letter is a critical milestone in the development of Savara’s drug for autoimmune pulmonary alveolar proteinosis (PAP). This letter is issued by the FDA to the sponsor of a new drug application (NDA) or a biologics license application (BLA) after the 74th day of the review period. The letter provides an update on the status of the review and highlights any major issues or concerns that need to be addressed.
<4> Background on Autoimmune PAP
Autoimmune PAP is a rare and life-threatening lung disease characterized by the accumulation of surfactant protein in the alveoli, leading to impaired gas exchange and respiratory failure. The disease is caused by an autoimmune response, where the body’s immune system mistakenly attacks the surfactant protein, leading to its accumulation in the lungs.
<5> Savara’s Drug Development Program
Savara is developing a novel drug for autoimmune PAP, which has shown promising results in preclinical and clinical studies. The company’s drug has been designed to target