California-based Raptor Pharmaceutical, a global biopharma that specializes in the development and commercialization of treatments for rare and debilitating diseases, recently announced that the U.S. FDA designated its inhaled levofloxacin treatment, MP-376, as a Qualified Infectious Disease Product (QIDP).
MP-376 treats chronic lung infections due to the bacterium Pseudomonas aeruginosa in three specific indications: patients with cystic fibrosis (CF); patients suffering from non-cystic fibrosis bronchiectasis (BE); and patients with nontuberculous mycobacteria (NTM).
Opportunistic pathogenic bacteria such as P. aeruginosa are well-known to cause or aggravate pulmonary diseases such as CF, BE, and NTM. Usually, these infections are treated using antibiotics, but P. aeruginosa identified as a prototypical multidrug-resistant pathogen has an advanced resistance to a variety of antibiotics.
MP-376 is an investigational form of inhaled formulation of the antibiotic levofloxacin, developed for the treatment of lung infections with P. aeruginosa. When MP-376 is administrated using the high-efficiency eFlow Nebulizer System (PARI Pharma GmbH), it delivers elevated concentrations of the active drug to the infected site in about five minutes. This offers MP-376 additional strength in fighting P. aeruginosa when compared to other antibiotics.
The QIDP designation will promote MP-376 as a treatment for a variety of serious life-threatening infections. It also provides the company with a number of key incentives related to the development of MP-376, such as priority review by the FDA, qualification for Fast Track designation, a five-year extension of market exclusivity, and regulatory flexibility.
“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., Raptor’s chief medical officer, said in a news 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.”