Pulmatrix, a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, has announced that its drug candidate for treating fungal infections in the lungs of CF patients, Pur1900, has been designated as a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration.
Under the QIDP programme, which is designed to speed the development of novel drugs against important pathogens, Pulmatrix will receive five years of additional market exclusivity for Pur1900.
In its letter to Pulmatrix, 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," said Pulmatrix chief executive officer Robert Clarke, PhD. "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."
Currently, many CF patients experience allergic reactions when their lungs become infected with a fungus called aspergillus. Doctors now try to treat those infections with oral drugs such as itraconazole. Oral antifungals require very high doses to get enough of the drug to the lungs through the bloodstream to fight the fungus, causing severe side effects, and oral antifungals are not always effective.
Pulmatrix's goal is to solve this problem by combining itraconazole with its innovative dry powder isperse technology. The combination of isperse and itraconazole makes it possible for patients to inhale the drug into their lungs, to the site of infection, where it's needed.
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"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," explained Pulmatrix's chief scientific officer, David L. Hava, PhD, "That should bring great benefits to patients."