Bristol-Myers Squibb (BMS; NYSE: BMY) announced this week that it has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for BMS-986278, its potential first-in-class lysophosphatidic acid receptor 1 (LPA1) antagonist. This oral treatment for progressive pulmonary fibrosis (PPF) is now set for expedited development and review, a significant step forward in addressing this life-threatening disease.
Phase II Trial Results
The FDA’s decision is based on promising results from a Phase II trial, which demonstrated that BMS-986278 was well tolerated and resulted in a 69% relative reduction in percent-predicted forced vital capacity (ppFVC) decline compared to placebo. These findings highlight the drug’s potential to significantly slow the progression of PPF, a condition characterized by the hardening and thickening of lung tissue.
Previous Regulatory Milestones
BMS-986278 has previously been awarded fast-track and orphan drug designations by the FDA for idiopathic pulmonary fibrosis (IPF), a related condition. These designations, along with the recent breakthrough therapy designation, underscore the regulatory commitment to facilitating the development and approval of new treatments for patients with limited therapeutic options.-Fineline Info & Tech
