According to Pulmatrix, the FDA has granted orphan drug status to the company’s PUR1900 itraconazole DPI for the treatment of fungal lung infections in cystic fibrosis patients, with the FDA stating, “Your designation is based on a plausible hypothesis that your drug may be clinically superior to the same drug that is already approved for the same indication.”
The dry powder formulation is based on Pulmatrix’s iSPERSE (inhaled small particles easily respirable and emitted) particle engineering technology.
Pumatrix CEO Robert Clarke commented, “This designation is a major boost to our efforts to make this drug available as quickly as possible to cystic fibrosis patients who currently suffer from fungal infections in their lungs, and from the allergic reactions they experience because of the fungal infections.”
Clarke added, “The estimated addressable market for improved antifungal treatments for CF is in the tens of thousands or patients per year, but the inhaled drug could also find much larger markets treating pulmonary fungal infections and other immunocompromised patients that could expand the addressable market to millions of patients per year.”
Read the Pulmatrix press release.
