It was reported yesterday that the US Food and Drug Administration (USFDA) has granted orphan drug designation to United States-based Onspira Therapeutics for its investigational product, OSP-101, intended for treating Bronchiolitis Obliterans.
The designation offers the potential for seven years of market exclusivity upon US Food and Drug Administration approval, along with prescription drug user fee waivers and tax credits for qualified clinical trials.
Onspira Therapeutics president and CEO, Brian Lortie, said, 'We are very pleased that FDA granted Orphan Drug Designation to OSP-101 for the treatment of Bronchiolitis Obliterans (BO). This is a significant milestone for Onspira, and we look forward to advancing the clinical program in coordination with the FDA and our advisors. BO is a relentless, progressive disease which causes significant mortality in affected patients, and our team is highly focused on providing an effective therapy to improve their lives.'
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