Pulmatrix has announced that its PUR1900 itraconazole DPI has received Qualified Infectious Disease Product (QIDP) designation for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients. PUR1900 received Orphan Drug designation in 2016 and QIDP status in January 2017 for the treatment of ABPA in cystic fibrosis patients.
Pulmatrix CEO Robert Clarke commented, “This second QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to severe asthma patients suffering from fungal lung infections. It will give us the benefit of an expedited regulatory review and significantly expands the potential population we can treat with our Pulmazole product. This designation provides Pulmazole with 5 years of market exclusivity for treatment of fungal lung infections in these patients with ABPA.”
Read the Pulmatrix press release.