Coronavirus pneumonia drug possible ‘by summer’ after FDA fast-tracks clinical trial

WASHINGTON — Medicine for the most severe respiratory symptoms caused by the coronavirus could clear clinical trials as soon as this summer, its manufacturer said on Monday, after receiving approval to test the drug from the Food and Drug Administration.

The FDA hopes that Actemra, which is already approved for use in the United States against rheumatoid arthritis, may also be able to relieve similar inflammations experienced by severely ill coronavirus patients who have pneumonia.

China listed Actemra in its treatment guidelines for patients severely ill from COVID-19, the disease caused by the coronavirus, in early March.

But the FDA-approved trial will be the first rigorous test of the drug for coronavirus patients, Levi Garraway, Roche’s chief medical officer, told McClatchy.

“In some types of viral pneumonia, the reason the pneumonia happens is not just because the virus is present, but because the inflammatory response can be exuberant,” Garraway said in a phone interview. “In China, some reasoned this could work against the (COVID-19) pneumonia, and they saw some results that were encouraging to them.”

Italian doctors have also experimented with the drug, with some promising results, Garraway said, motivating Roche to approach the FDA for fast-track approval.

“Our goal is to start the study as early as possible in April. We’re working day and night to get it started,” said Garraway.

The Phase III trial – the last stage before a drug is approved for market use by the FDA – could then be completed by summer, Garraway said. “Summer is a timeframe that seems reasonable.”

The FDA would then make a decision whether to issue an emergency approval of the drug for widespread availability.

The Department of Health and Human Services has also directed Genentech, a member of the Roche pharmaceutical group and the producer of Actemra, to provide 10,000 vials of the drug to the Strategic National Stockpile.

President Donald Trump has publicly directed the FDA to speed up its approval of existing drugs or drug cocktails that have shown anecdotal promise in treating COVID-19.

Doctors on the White House coronavirus task force have urged caution against providing the public with “false hope,” as scientists first begin the monthslong process of testing the effectiveness and safety of certain drugs and their dosages on coronavirus patients.

The FDA has recently authorized trials for remdesivir, which is also undergoing trials in China, and approved a combination of hydroxychloroquine and zithromax for compassionate use — a term used by doctors to request off-label use of drugs for critically ill patients.

FDA Commissioner Stephen Hahn said those trials would take months to complete, and that the agency would go through the “regular process” before authorizing the public use of any drug for treatment of COVID-19.

Earlier this month, as the coronavirus outbreak expanded across the United States, the Trump administration turned to Roche, a Swiss company, for the mass production of coronavirus test kits that could be rapidly processed.

Roche is one of many companies with diagnostic expertise “devoting intense resources” to the development of tests, treatments and vaccines for the virus, Garraway said.

“The big picture is, there are a number of medicines out there, all of which were approved for other indications, where there are interesting hypotheses that they may be used against the coronavirus,” said Garraway. “The availability will depend on, No. 1, is it effective and safe. Until we see data, we can’t speculate.”