Microbion Corporation said that its pravibismane inhalation suspension for the treatment of lung infections in patients with cystic fibrosis has been granted orphan drug designation by the FDA. Pravibismane inhalation suspension has already been granted Fast Track and Qualified Infectious Disease Product (QIDP) designations for that indication.
According to the company, pravibismane demonstrates activity agains multi-drug resistant P. aeruginosa and other multi-drug resistant organisms, as well as against biofilms. Microbion is also developing pravibismane as a topical formulation for the treatment of diabetic foot ulcers and for infections in orthopedic implants.
Microbion Pharma Corp Chairman and CEO Karim Lalji commented, “We are pleased to have been granted orphan drug designation for our pravibismane inhalation program. 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 Microbion Corporation press release.
