The FDA designation adds five years of market exclusivity for Pulmatrix' inhaled product for treating fungal infections in the lungs of CF patients
Under the QIDP program, which is designed to speed the development of novel drugs against important pathogens, Pulmatrix will receive five years of additional market exclusivity for PUR1900.
the FDA wrote: "We have reviewed your request and conclude that it meets the criteria for QIDP. Therefore we are designating your Itraconazole Inhalation Powder (PUR1900) product for inhalation use as a QIDP for….treatment of pulmonary Aspergillus infections in patients with cystic fibrosis."
"The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic fibrosis ( CF ) patients suffering from fungal lung infections.
"It will give us the benefit of an expedited regulatory review.
Added to our existing FDA Orphan drug designation for PUR1900, it will give us a full 12 years of market exclusivity."
"By delivering the drug directly to the lungs, we should be able to fight the infection far more effectively than the oral drug can, with far fewer side effects,"