Raptor Pharmaceutical’s MP-376 (Inhaled Levofloxacin) granted QIDP Status by the FDA on March 16, 2016.
What is Qualified Infectious Disease Product (QIDP) Designation?
QIDP status gives a drug priority review by the FDA, eligibility for Fast Track designation, and an extension of marketing exclusivity. This incentivizes pharmaceutical companies to devote resources to developing antimicrobial medications to treat life-threatening infections.
What is Inhaled Levofloxacin?
Levofloxacin is a fluoroquinolone antibiotic used to treat pulmonary and other infections. In its oral form, it’s also known as Levaquin.
Inhaled Levofloxacin is intended to deliver the antibiotic directly to the site of the infection via a nebulizer. This medication, also known as QUINSAIRTM, is approved in the EU and Canada for chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with CF. It’s inhaled via the eFlow from PARI.
MP-376 is the investigational form of QUINSAIRTM being developed in the U.S, also for P. aeruginosa infections in adult patients with CF.
MP-376 is also being developed to treat P. aeruginosa in patients with non-CF bronchiectasis, and in patients with pulmonary Non-Tuberculosis Mycobacterium (NTM) infections.