Raptor Pharmaceutical Corp. announced that its proprietary inhaled levofloxacin, MP-376, has been given Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA) to treat three specific indications:
- chronic pulmonary infections caused by Pseudomonas aeruginosa
- cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis
- nontuberculous mycobacteria (NTM)
Raptor is working toward FDA approval of MP-376, an antibiotic, as a CF treatment, and is pursuing clinical programs in the remaining indications. The antibiotic is administered using the eFlow Nebulizer System (PARI Pharma GmbH), allowing for the quick delivery of high concentrations of active drug directly to the infection site.
“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,” said Raptor Pharmaceutical’s chief medical officer, Krishna Polu, 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 CF in the second quarter and initiating a Phase 2 program in bronchiectasis this year.”
The QIDP designation, created in 2012, encourage pharmaceutical companies to develop antimicrobial drugs to treat serious and life-threatening infections through incentives that include priority review, Fast Track designation eligibility, and a five-year extension of marketing exclusivity.
MP-376 is the investigational product of Raptor’s Quinsair, which is an inhaled form of levofloxacin, a fluoroquinolone antibiotic, being developed for the management of P. aeruginosa chronic pulmonary infections in CF patients. Quinsair is already approved for that indication in the EU and Canada, the company said in the release.
Raptor plans to begin a Phase 2 clinical trial of MP-376 in non-CF bronchiectasis by the end of 2016, and to continue clinical development of the drug to treat NTM-associated lung infections.