The FDA Extends Review of REGEN-COV
The FDA needs to review additional data from a trial that assessed REGEN-COV for the prevention of COVID-19. The new PDUFA date is July 13, 2022.
The FDA has extended by three months its review of the biologics license application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and a preventive medication for some people.
Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review. The FDA considers the submission of these additional data to be a major amendment to the BLA and has provided a new target action date of July 13, 2022. The FDA has not requested any new studies.
REGEN-COV contains two monoclonal antibodies that are designed to block infection of SARS-CoV-2. It first became available in November 2020 under an emergency use authorization, but in January 2022 the FDA limited the EUA in the areas where the omicron variant of the virus was circulating saying the treatment was not effective against this variant. Currently, REGEN-COV is not currently authorized in the United States.
Regeneron submitted data for full approval in October 2021. This was based on two positive phase 3 trials involving more than 6,000 patients in non-hospitalized patients and as prophylaxis.
Related: FDA Monoclonal Antibody Decision Pulled Into Political Fray
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs
December 19th 2024The Institute for Clinical and Economic Review assessed the formularies of 11 payers, covering 57 million people, to determine access for drugs that the organization had reviewed in 2022 for cost-effectiveness.
Read More
