FDA stresses urgent need for COVID-19 treatments with launch of Coronavirus Treatment Acceleration Program

Though 72 potential vaccines and treatments for COVID-19 are currently under development, the U.S. Food and Drug Administration (FDA) and its federal health partners note that urgency for additional products remains, and to jumpstart possibilities, they have launched a new Coronavirus Treatment Acceleration Program (CTAP).

CTAP has two simultaneous goals: to get new treatments to patients as quickly as possible and to assess their abilities to help or harm. Short and long-term solutions alike remain necessary, as the certainty of none has been ascertained, and the federal government desires options as quickly as possible.

“We should start to receive data from a variety of clinical studies of different types of products soon,” said Drs. Stephen Hahn, FDA Commissioner; Peter Marks, Director of the Center for Biologics Evaluation and Research; and Janet Woodcock, Director of the Center for Drug Evaluation and Research in a statement released this week. “When we do, we intend to use a flexible and innovative approach. Once we observe favorable results, we intend to be very proactive about patient access.”

While validity studies by researchers — not the FDA — are underway, the partners stressed the need for medicines to bridge the gap left by a lack of vaccines.

“Patients with the disease need more treatment options, depending on the disease’s severity and stage,” the partners wrote. “First responders and essential front-line workers urgently need medicines to reduce the risk of getting infected. The FDA has worked hard to facilitate access to promising therapeutics for sick patients through our Expanded Access program, while data from clinical trials is generated. We are also working with industry to anticipate and address complex manufacturing challenges—for example, to reduce disruption to the supply of medications.”

Studies are being accepted and accelerated include direct-acting antivirals, a treatment that dials back the body’s immune system to keep the virus from causing it to short circuit and attack itself, and plasma-based antibodies taken from those who have survived COVID-19 infection, among others.