Wicker: FDA should increase access to lifesaving treatments.

Today, U.S. Senator Roger Wicker urged the Food and Drug Administration (FDA) to consider all available options to expedite access to several new COVID-19 therapies that are currently under development.

“The arrival of new COVID-19 therapies could prove pivotal in ending our country’s long and challenging battle with the coronavirus pandemic,” Wicker said. “The FDA must do all it can to expedite access to lifesaving treatments now under development.”

The FDA created the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program for possible coronavirus therapies. CTAP uses every available method to move new treatments to patients as quickly as possible, while finding out whether they are helpful or harmful.

As of August 31, 2021, over 470 trials have been reviewed by the FDA, more than 640 drug development programs in planning stages, 11 COVID-19 treatments currently authorized for Emergency Use, and one treatment is currently approved by FDA for use in COVID-19.

The FDA is currently reviewing an application from drugmakers Merck and Ridgeback Biotherapeutics for emergency use authorization of the antiviral drug molnupiravir. Molnupiravir, an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world,” said Robert M. Davis, chief executive officer and president, Merck.

The FDA has also received an application from drugmaker AstraZeneca to authorize use of an antibody therapy to prevent symptomatic COVID-19 for patients whose immune systems make traditional vaccines less effective.

“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines. We look forward to sharing AZD7442 data for the treatment of COVID-19 later this year,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.

There are several other COVID-19 antiviral therapies from a variety of manufacturers that are currently under development.