FDA approve Lilly-Incyte’s treatment for hospitalised COVID patients

pharmafile | May 12, 2022 | News story | Business Services  

The FDA has granted approval for Eli Lilly and Incyte’s Olumiant (baricitinib) to treat COVID-19 in adult patients admitted to the hospital. The drug is a Janus kinase (JAK) inhibitor and is approved for patients requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

The approval is supported by results from two randomised, double-blind, placebo-controlled Phase III studies (ACTT-2 and COV-BARRIER, which includes the COV-BARRIER OS7 addendum study.

“More than two years into the pandemic, COVID-19 is still hospitalizing many people and burdening our healthcare system. I’m grateful to have OLUMIANT as a treatment option for those who require various degrees of respiratory support, from supplemental oxygen to mechanical ventilation or ECMO,” said Andre Kalil, MD, MPH, Professor of Medicine at the University of Nebraska Medical Center and principal investigator of the Adaptive COVID-19 Treatment Trial 2 (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

“I’m encouraged by the FDA’s full approval of OLUMIANT for the treatment of these patients based on results from the rigorous, placebo-controlled, double-blind, randomized trials. While there are therapies currently available, there is still an urgent need for more options to help improve outcomes for patients hospitalized due to COVID-19.”

In the two Phase III studies, no new safety signals potentially related to the use of Olumiant were identified. Baricitinib received an Emergency Use Authorisation (EUA) in November 2020, applicable for hospitalised paediatric patients of the age two to below 18 years, in need of varying levels of oxygen support.

“Nearly one million people with COVID-19 have been treated with Olumiant (baricitinib) in approximately 15 countries worldwide,” said Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. “Today’s full approval reflects both our confidence in Olumiant’s role in treating these hospitalized patients and Lilly’s tireless efforts to support the medical community and patients in the ongoing fight against COVID-19.”

Ana Ovey

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