Orphan drug designation granted for treatment of pulmonary infections in patients with cystic fibrosis
The U.S. Food and Drug Administration has granted orphan drug designation for inhalation delivery of pravibismane (BisEDT antimicrobial suspension) for treatment (management) of pulmonary infections in patients with cystic fibrosis.
“We are pleased to have been granted orphan drug designation for our pravibismane inhalation program,” said Mr. Karim Lalji, Chairman and CEO of Microbion Pharma Corp in a press release. “This designation is consistent with our steadfast commitment to develop innovative solutions to manage chronic pulmonary infections in patients with CF. We will work closely with the FDA and key stakeholders to advance inhaled pravibismane toward regulatory approval for the benefit of patients with cystic fibrosis.”
Read the full press release here.