The World Health Organization (WHO) has recommended two new drugs to treat COVID-19—baricitinib and sotrovimab.
Baricitinib, an oral drug, is “strongly recommended” for people with severe or critical COVID-19, to be given with cortico steroids, the WHO announced.
Baricitinib is part of a class of drugs called Janus kinase (JAK) inhibitors, which suppress the overstimulation of the immune system. The drug is also used to treat rheumatoid arthritis.
The WHO’s Guideline Development Group found “moderate certainty evidence that baricitinib improved survival and reduced the need for ventilation, with no observed increase in adverse effects.”
Sotrovimab is “conditionally recommended” for people with mild or moderate COVID-19 but at “high risk” of hospitalization. This includes people who are “older, immunocompromised, having underlying conditions like diabetes, hypertension, and obesity, and those unvaccinated,” stated the United Nations agency.
Sotrovimab is administered as a single intravenous infusion over 30 minutes. It is a monoclonal antibody drug, and can be used as an alternative to casirivimab-imdevimab, another monoclonal antibody that the WHO recommended in September 2021. Monoclonal antibodies are lab-created proteins designed to act like human antibodies in the immune system.
“Studies are ongoing on the effectiveness of monoclonal antibodies against Omicron but early laboratory studies show that sotrovimab retains its activity,” the agency stated.
The recommendation on Jan. 14 is the eighth update of the agency’s living guidelines on therapeutics and COVID-19, published in the British Medical Journal, and is based on evidence from seven trials encompassing over 4,000 patients with COVID-19 ranging from non-severe to critical.
The panel of experts behind the guidelines also reviewed information regarding two other drugs for severe and critical COVID-19—JAK inhibitors ruxolitinib and tofacitinib.
They determined that evidence from small trials “failed to show benefit and suggested a possible increase in serious side effects with tofacitinib.” The WHO has since made a conditional recommendation against their use.
Humanitarian organization Médecins Sans Frontières (MSF) applauded the new WHO recommendation for baricitinib. In a statement, the group urged governments to take steps to make sure that patent protections “do not stand in the way of access to this treatment.”
MSF noted that U.S. pharmaceutical company Eli Lilly filed and obtained patents widely, including in Brazil, Russia, South Africa, and Indonesia, therefore blocking the production of affordable versions of baricitinib.
“Despite the fact that baricitinib is already approved for other conditions like rheumatoid arthritis—and generic versions are already available in India and Bangladesh at much lower prices than those being charged by Eli Lilly—baricitinib will not be widely available to treat COVID-19 as long as the company continues to block the generic production in most places,” MSF stated.
“An Indian manufacturer priced baricitinib at $5.50 per treatment course of 4mg once per day for 14 days, and the lowest listed price in Bangladesh (pdf) is $6.70. This is nearly 400 times less than Eli Lilly’s exorbitant listed price in July of $2,326 per treatment course.”