FDA Gears Up for Second Wave of COVID-19 Treatments

The FDA’s Coronavirus Treatment Acceleration Program is gearing up for a second wave of potential COVID-19 treatments and vaccines as the search for effective products gains momentum.

The program has logged almost 1,000 inquiries for COVID-19 drugs as of April 16, and the agency is monitoring 72 clinical trials and more than 200 development programs.

Multiple trials are underway to evaluate different approaches to treatment, such as antivirals, immunosuppressants and antibody-based therapies.

Besides Gilead’s promising antiviral remdesivir, which is in multiple studies, trials are underway to evaluate interleukin-6 (IL-6) inhibitors and Janus kinase inhibitors, commonly used to treat rheumatoid arthritis. Novartis’ Jakavi (ruxolitinib), for example, is currently being studied for treatment of severe immune reactions in COVID-19 patients.

Another potential treatment centers on the use of plasma from COVID-19 survivors. In a program led by the Mayo Clinic, more than 1,600 sites nationwide have signed on to offer convalescent plasma to COVID-19 patients outside of clinical trials.

Hyperimmune globulin derived from convalescent plasma should be ready for clinical trials soon, the agency said. It is more versatile than plasma because it does not need to be matched to the patient’s blood type. — Jordan Williams