The U.S. Food and Drug Administration has granted Qualified Infectious Disease Product (QIDP) designation to MP-376, Raptor Pharmaceutical’s inhaled levofloxacin to treat pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis; non-cystic fibrosis bronchiectasis (BE); and nontuberculous mycobacteria (NTM).
Raptor, based in Novato, California, is a global biopharma that’s focused on developing and commercializing therapies for rare, debilitating, and often fatal diseases.
MP-376 (inhaled levofloxacin hemihydrate) is the investigational form of Quinsair, an inhaled formulation of levofloxacin, a fluoroquinolone antibiotic. The fluoroquinolones rapidly inhibit replication and transcription of bacterial DNA, leading to bacterial cell death. Administration of MP-376 with a high-efficiency nebulizer allows delivery of high concentrations of the drug directly to the site of infection in about five minutes.
QIPD designation was crafted from the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act, legislation created to offer incentives for the development of new antibiotic agents that target serious life-threatening infections.
The QIDP designation emphasizes MP-376’s potential for the treatment of serious and life-threatening infections, and provides the company with incentives for its development, including priority and expedited review by the FDA, eligibility for Fast Track designation, and a five-year extension of marketing exclusivity under the Hatch-Waxman Act.
The FDA has also granted MP-376 Orphan Drug designation for the treatment of cystic fibrosis. If the drug is granted approval for clinicial use, this designation will give it seven years of market exclusivity.
“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,” Krishna Polu, M.D., chief medical officer of Raptor Pharmaceutical, said in a press release.
“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 cystic fibrosis in the second quarter and initiating a Phase 2 program in bronchiectasis this year,” Polu said.