The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will provide additional support for the development of Kevzara as a potential treatment for COVID-19.
Kevzara — developed under a collaboration between Regeneron and Sanofi — is approved by the U.S. Food and Drug Administration for the treatment of rheumatoid arthritis. The companies are continuing to collaborate on studying Kevzara for COVID-19. Regeneron is leading U.S.-based trials and Sanofi leading trials outside the U.S.
HHS will provide support for a U.S. Phase 2/3 clinical trial to evaluate Kevzara as a potential treatment.
“We are working at a record pace with our private sector partners to speed development of therapeutic treatments for people with COVID-19,” Rick Bright, director of the Biomedical Advanced Research and Development Authority, which is part of ASPR, said. “By repurposing a currently approved product, we may be able to expedite development and make treatments available quickly.”
Patients with COVID-19 are at risk of developing respiratory failure, which may be mediated in part by elevated levels of a series of pro-inflammatory molecules, including interleukin-6 (IL-6). Kevzara is an antibody that binds to the IL-6 receptor on normal cells and may improve patient outcomes by decreasing the severe inflammatory response.
The role of IL-6 is supported by preliminary uncontrolled data from a Chinese trial of a different IL-6 agent, which showed rapid reductions in fever in all patients and improvements in oxygenation. The Phase 2/3 clinical trial will determine if Kevzara can be used to reduce the amount of time that a person infected with the novel coronavirus remains ill.
HHS continues to work across the U.S. government to review potential products from public and private sectors to identify promising candidates to treat COVID-19 for development and FDA approval.
“Proven treatment options for COVID-19 are urgently needed. This trial of Kevzara is critical to inform doctors on treatment options for COVID-19,” HHS Secretary Alex Azar said. “The close collaboration between BARDA, the FDA, and Regeneron to initiate this trial as soon as possible again demonstrates the speed at which we are responding to this pandemic.”