According to Pulmatrix, its PUR1900 itraconazole DPI for the treatment of pulmonary aspergillus infections in cystic fibrosis patients has received Qualified Infectious Disease Product (QIDP) designation from the FDA.
Pulmatrix CEO Robert Clarke commented, “The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic fibrosis patients suffering from fungal lung infections. It will give us the benefit of an expedited regulatory review. Added to our existing FDA Orphan drug designation for PUR1900, it will give us a full 12 years of market exclusivity.”
In August 2015, the company announced plans for a Phase 1 trial of PUR1900 within the next year and a half; according to the Pulmatrix website, the product is currently still in preclinical development.
Read the Pulmatrix press release.
