Roche, Sanofi arthritis drugs score WHO backing for severe COVID-19, but agency echoes calls for lower prices

Roche
Two weeks ago, Roche's Actemra was approved for use in severely ill COVID-19 patients, along with corticosteroids. Now the World Health Organization has followed suit, recommending Actemra and another IL-6 rheumatoid arthritis drug, Sanofi/Regeneron's Kevzara. (Roche)

Using IL-6 rheumatoid arthritis drugs—such as those from Roche and Sanofi—along with corticosteroids in severely ill COVID-19 patients has been the subject of fierce debate and has produced mixed results in testing since Chinese doctors proposed the strategy early last year.

But over time, use of the drugs has gained acceptance. Now the World Health Organization has added its stamp of approval, recommending Roche’s Actemra and Sanofi and Regeneron’s Kevzara with corticosteroids after concluding that the drugs reduce the risk of death in those with severe COVID-19.

Those severely ill with COVID-19 often have an overreaction of the immune system. IL-6 receptor antagonists, such as Actemra and Kevzara, suppress the overreaction, WHO said. Still, the drugs are too expensive to be deployed in many areas of the world, the agency said.

RELATED: Roche nabs FDA emergency nod for Actemra in severe COVID-19 despite mixed results

This is the first class of drugs the WHO has recommended for use against COVID-19 since last September when the global agency green-lighted corticosteroids.

The WHO based the decision on an analysis of 27 clinical trials involving 10,930 patients around the world. The studies showed use of the drugs reduced the risk of death by 13% and the risk of progressing to mechanical ventilation by 28% compared with standard care.

“These drugs offer hope,” WHO director general Tedros Adhanom Ghenbreyesus said in a statement. “But IL-6 receptor blockers remain inaccessible and unaffordable for the majority of the world.”

The move comes two weeks after the FDA authorized Actemra for COVID-19 patients requiring some oxygen support. In November of last year, the FDA endorsed the use of another rheumatoid arthritis treatment, Eli Lilly’s Olumiant, in combination with Gilead’s antiviral Veklury for patients needing oxygen.

In January, the U.K. recommended the use of Actemra and Kevzara for severely ill COVID-19 patients.

RELATED: Roche’s Actemra, Regeneron’s Kevzara win U.K.’s favor in COVID-19 after study shows 24% drop in death risk

Many doctors have already been using these drugs as a last resort for severely ill COVID-19 patients. Actemra sales reached $3.12 billion last year, a 32% jump from 2019, thanks to a COVID-19 boost. Sanofi reported a 30% sales jump for Kevzara.

The WHO called on manufacturers to reduce the prices for these drugs, especially in countries where the virus is surging. A 20 mg dose of Actemra costs $491.

“The inequitable distribution of vaccines means that people in low- and middle-income countries are most susceptible to severe forms of COVID-19,” Ghenbreyesus said. “The greatest need for these drugs is in countries that currently have the least access. We must urgently change this.”

Aside from the WHO, global aid group Doctors Without Borders has also called for lower prices.