The FDA has granted Qualified Infectious Disease Product (QIDP) designation to Raptor Pharmaceutical’s MP-376 inhaled levofloxacin for the treatment of chronic P. aeruginosa lung infections in patients with cystic fibrosis, non-cystic fibrosis bronchiectasis (BE), and nontuberculous mycobacteria (NTM). Raptor has previously received orphan designation from the FDA for the CF indication.
MP-376 is an investigational version of Quinsair (formerly Aeroquin), which Raptor acquired from Tripex Pharmaceuticals in 2015. Quinsair is approved in Canada and the EU for the treatment of adult patients with CF, and the company says that it plans to begin a Phase 2 study in non-CF BE patients by the end of the year.
Raptor Chief Medical Officer Krishna Polu commented, “We are pleased with the FDA’s decision to grant QIDP designation to MP-376 as we believe this drug has the potential to provide a significant benefit in the treatment of P. aeruginosa infections in patients with CF and in other chronic pulmonary infections in patients with bronchiectasis and nontuberculous mycobacteria. Importantly, this designation validates the unmet need caused by a growing number of persistent lung infections which can result in death in these patients. QIDP designation will help to facilitate the development of MP-376 in these indications. We look forward to having regulatory discussions with the FDA in CF in the second quarter and initiating a Phase 2 program in bronchiectasis this year.”
Read the Raptor press release.
