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Under pressure, FDA touts speedy coronavirus drug development

The Food and Drug Administration has made official its urgency in hastening development of drugs to treat COVID-19, branding its efforts as part of a newly announced Coronavirus Treatment Acceleration Program, or CTAP. The regulator gave a full listing of CTAP activities in a statement Tuesday, noting it’s redeployed staff and prioritized company requests. FDA reviewers have turned around study protocol approvals in 24 hours, and single-patient expanded access requests within three hours, the agency said. Treatments for COVID-19 are desperately needed, as doctors and nurses have little else besides supportive care to offer patients. Yet there are concerns experimental drugs could be pushed forward with only thin evidence to support their use. Senior government health officials told​ Politico, for instance, that the White House’s focus on unproven malaria drugs has distracted from efforts to advance other promising treatments.

The U.S. has become the epicenter of the global pandemic, with a total of 141,000 cases and 2,400 deaths as of March 31, according to the World Health Organization. The White House has now acknowledged that the death toll in the country could rise to between 100,000 and 240,000.

Vaccines, such as those being developed by Moderna Therapeutics, Johnson & Johnson, Sanofi and others, will likely arrive too late to change those numbers.

The Biomedical Advanced Research and Development Authority on Monday said it will be supporting a Phase 1 trial of J&J’s vaccine candidate to begin this autumn and help it to accelerate large-scale manufacturing, along with helping Moderna prepare for Phase 2 and 3 trials. But top officials have emphasized a vaccine for SARS-CoV-2, as the coronavirus is official known, is a year to 18 months away at the earliest.

Drugs that impede the virus or treat COVID-19 complications, however, could still make a difference, if they can reach patients quickly enough. The problem is that the standard drug approval process is cautious by nature, designed to rule out major safety risks first before experimental drugs are used in trials large enough to prove a clinical benefit. With CTAP, the FDA is trying to streamline as many aspects of that process as it can.

Gilead Sciences’ experimental antiviral remdesivir was one of the first to be sped into coronavirus patients, while the anti-inflammatory drugs Actemra from Roche and Kevzara from Sanofi have been authorized for experimental use in some coronavirus patients with respiratory distress.

Another approach has been to use the antibody-rich blood products from recovered patients to help infected patients fight the virus. The antimalarial drugs chloroquine and hydroxychloroquine have also drawn attention, particularly from President Donald Trump, but the decades-old pills are surrounded by controversy over their effectiveness and cardiovascular side effects.

Earlier this week, the FDA cleared two forms of the drugs for emergency use, allowing the distribution of millions of doses from a federal stockpile to states.

The FDA’s announcement of the CTAP formalizes many of the activities that allowed those studies to get off the ground. The agency has redeployed medical and regulatory staff onto dedicated coronavirus response teams, streamlined the processes for requesting technical support and reviews of drug trials, and given practitioners and researchers tools to make emergency requests to use experimental drugs.

To speed the review of trial drugs, the FDA said it is developing real-world data tools to analyze outcomes and illness patterns, which it says will supplement placebo-controlled trials.