Raptor Pharmaceutical Corp. (NASDAQ:RPTP) reported that the U.S. FDA has approved Qualified Infectious Disease Product designation to its lead candidate MP-376. It is the firm’s proprietary inhaled levofloxacin meant for the treatment of three distinct indications: for the cure of chronic pulmonary infections resulting from Pseudomonas aeruginosa, and in patients suffering with cystic fibrosis, in patients having non-cystic fibrosis bronchiectasis, and in people suffering with nontuberculous mycobacteria.
The QIDP designation was established under the GAIN Act of 2012 for encouraging pharmaceutical firms to advance new antimicrobial medications to treat life-threatening and serious infections. The FDA approval of the QIDP designation to Raptor’s MP-376 suggests the drug’s potential to address numerous life-threatening and serious infections.
It offers Raptor with substantial incentives for the advancement of MP-376, counting priority assessment by the FDA, a five-year extended period of marketing exclusivity falling in the Hatch-Waxman Act, and admissibility for Fast Track status. QIDP opens the way for the FDA to apply increased regulatory flexibility in events of high unmet medical need for life-threatening diseases. Raptor possess orphan status in the United States for ‘MP-376’ targeting treatment of CF, which, if receives approval, confers market exclusivity of seven years.
The management view
Krishna Polu, M.D., the Chief Medical Officer of Raptor, said that they are delighted with the FDA’s decision to approve QIDP designation for MP-376. They believe that this medication holds the potential to offer a considerable benefit in the cure of P. aeruginosa infections in individuals suffering with CF. These benefits even extend to other chronic pulmonary infections in individuals suffering with nontuberculous mycobacteria and bronchiectasis.
More importantly, QIDP designation authorizes the unmet need instigated by an increasing number of serious lung infections. QIDP status will help to boost the advancement of MP-376 drug to treat these indications. Raptor team look forward to conducting regulatory talks with the FDA on the same matter in the second quarter and beginning a Phase 2 trial in bronchiectasis this year.