Pulmatrix Inc (NASDAQ:PULM), a clinical stage biopharmaceutical firm developing innovative inhaled treatments to address serious pulmonary diseases, reported that its drug candidate for curing fungal problems in the lungs of CF patients, named PUR1900, has been given “Qualified Infectious Disease Product” status by the U.S. Food & Drug Administration.
The details
Under the QIDP plan, which is designed to boost the advancement of novel drugs against vital pathogens, Pulmatrix will get 5 years of more market exclusivity for “PUR1900.” In its letter to company, the FDA mentioned that they have assessed their request and concluded that it fulfills the criteria for QIDP. Hence, they are designating their Itraconazole Inhalation Powder product for inhalation use with QIDP designation for cure of pulmonary Aspergillus infections in subjects with cystic fibrosis.
Robert Clarke, PhD, the CEO of Pulmatrix, said that the QIDP designation is a strong boost to their measures to make this medication available soon to cystic fibrosis people dealing with fungal lung infections. It will give them the benefit of a faster regulatory assessment. Added to their current FDA Orphan drug status for PUR1900, it will provide them a full 12-years of market exclusivity.
In present scenario, many CF patients face allergic reactions due to lungs infection, which is caused by a fungus known as Aspergillus. Physicians now try to cure those infections with oral medications such as itraconazole. Oral antifungals need high dosage to get enough of the medication to the lungs via the bloodstream to fight the fungus, resulting in severe side effects. Moreover, oral antifungals may or may not be effective.
Pulmatrix’s objective is to solve this issue by combining itraconazole with its unique dry powder iSPERSE™ know-how. The combination of itraconazole and iSPERSE™ makes it possible for people to inhale the medications into their lungs, to the place of infection.
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