Therapy Areas: Vaccines
Bristol Myers Squibb Posts Topline Results Showing Treatment with Orencia Improved Survival in People Hospitalized with COVID-19
3 June 2022 - - US-based biopharmaceutical company Bristol Myers Squibb (NYSE: BMY) has posted topline results from the Phase 3 Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-1) Immune Modulators clinical trial, sponsored by the National Institutes of Health, the company said.

The study evaluated the safety and efficacy of a single dose of immune modulators, including Orencia (abatacept) IV (10 mg/kg) versus placebo when given with standard of care to determine if modulating the immune system's response could speed recovery and reduce death in adults hospitalized with moderate to severe COVID-19.

Treatment with Orencia versus placebo displayed a strong but not statistically significant improvement in the primary endpoint of time to recovery as measured by day of hospital discharge.

Analyses of the secondary endpoints, which included mortality and clinical status, demonstrated Orencia reduced participants' risk of death and improved their clinical status at 28 days after entering the study when compared with placebo.

The risk of death was lower for participants who received Orencia at 11%, versus 15% for those who received placebo, and the odds of dying were 37.4% lower.

The relative improvement in mortality was similar in both moderately and severely ill participants.

People in the Orencia group had 34.2% better odds of clinical improvement than those in the placebo group. The safety profile of Orencia remained consistent, with no new safety signals reported in the study.

The full report on these data will be published in a peer-reviewed scientific journal. Given the positive findings from the topline data, Bristol Myers Squibb plans to discuss these data and potential next steps with the US Food and Drug Administration.

Orencia is a selective costimulation modulator that disrupts the continuous cycle of T-cell activation.

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb company. In certain countries outside the US, due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
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