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  • USFDA grants...

USFDA grants Breakthrough Therapy Designation for Bristol Myers Squibb BMS-986278 for Progressive Pulmonary Fibrosis

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-10-26T12:30:32+05:30  |  Updated On 26 Oct 2023 12:30 PM IST
Bristol Myers Squibb bags European Commission approval for Opdivo combo in lung cancer treatment
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Princeton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, for the treatment of progressive pulmonary fibrosis (PPF), a devastating, life-threatening illness. Currently, there is only one therapy approved for the treatment of PPF.

The Breakthrough Therapy Designation is based on results from the global, randomized Phase 2 study that assessed the safety and efficacy of BMS-986278 treatment versus placebo in people living with idiopathic pulmonary fibrosis (IPF) and PPF. Stable background use of antifibrotics in the IPF cohort and/or select immunosuppressives in the PPF cohort were allowed. Results from the PPF cohort showed that 26 weeks of treatment with a twice-daily 60 mg dose of BMS-986278 resulted in a 69% relative reduction in the rate of decline in percent predicted forced vital capacity versus placebo. Treatment effect was consistent with or without background therapy and BMS-986278 was well tolerated, with rates of adverse events similar to placebo and low discontinuation rates. These findings were presented at the European Respiratory Society (ERS) 2023 International Congress in September 2023.

Breakthrough Therapy Designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening diseases with preliminary clinical evidence that the investigational therapy may offer substantial improvement on at least one clinically significant endpoint over available therapies.

“People living with pulmonary fibrosis face deteriorating lung function, worsening respiratory symptoms and reduced quality of life, which can ultimately lead to respiratory failure and death,” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience Development, Bristol Myers Squibb. “The FDA’s Breakthrough Therapy Designation underscores the potential of BMS-986278 as an innovative, first-in-class treatment that may redefine the standard of care for progressive pulmonary fibrosis.”

In addition to this Breakthrough Therapy Designation for PPF, the U.S. FDA has also previously granted BMS-986278 fast-track designation and orphan drug designation for the treatment of IPF. Bristol Myers Squibb is continuing the development of BMS-986278 with the global Phase 3 ALOFT program for PPF (NCT06025578) and IPF (NCT06003426).

Read also: Bristol Myers Squibb, Paradigm collaborate to build new model for clinical trials

Bristol Myers SquibbBristol Myers Squibb newsUSFDABMS 986278progressive pulmonary fibrosis
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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