A drug currently approved to treat arthritis and now being studied as a possible treatment for COVID-19, the disease caused by the new CCP virus from China, was sent to doctors in the United States, the company that manufactures the drug said.
Alexander Hardy, chief executive of Roche’s Genentech business, said this week that the company sent 10,000 vials of the Actemra drug to the Strategic National Stockpile.
The vials are meant for potential use in COVID-19 treatment at the direction of the Department of Health and Human Services, according to a company press release.
The prescriptions would be another example of off-label use, where a drug approved for one use is prescribed for another. Hydroxychloroquine, a drug approved to treat malaria, is also among the drugs being prescribed by doctors for COVID-19 patients.
Chinese doctors have reported favorable outcomes from using the drug and it’s also being studied in France. Roche has also heard of positive anecdotal reports from New York, Hardy said.
Study
In a separate update on Tuesday, Roche confirmed it initiated a randomized, double-blind, placebo-controlled Phase III clinical trial of Actemra, the first global study of the drug’s potential efficacy in treating COVID-19.The study is being done in collaboration with the Biomedical Advanced Research and Development Authority, which is part of the Health and Human Services Office of the Assistant Secretary for Preparedness and Response.
Researchers are evaluating the safety and efficacy of the drug, also known as tocilizumab, on top of standard of care in adults with severe cases of COVID-19, in comparison to a placebo on top of standard care.
“In addition to the Roche trial, Roche is also carefully following independently-led clinical trials, on multiple medicines including Actemra, that are taking place around the world,” Roche stated.
“At the moment, there are no robust, well-controlled studies showing safety and efficacy of Actemra in clinical treatment of COVID-19 pneumonia, and Actemra is not currently approved for this use,” it added.
The study was approved by the Food and Drug Administration on Monday.
“We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and we’re moving forward to enroll as quickly as possible,” Hardy said in a statement.