The World Health Organisation (WHO) has added the Regeneron antibody drug cocktail – casirivimab and imdevimab – to its list of treatments for people with COVID-19, urging the manufacturer to reduce the price and ensure equitable distribution.
Clinical studies showed the drug combination was effective in patients who were not severely ill but at high risk of being admitted to hospital with COVID-19, or those with severe cases of the disease and no existing antibodies, the WHO said in a statement on Friday.
It is the first drug against COVID-19 the WHO has recommended for use in non-severe high-risk patients to reduce the chances of the disease progressing.
The antibody therapy secured emergency use authorisation in the United States in November last year after it was used to treat former President Donald Trump when he was admitted to hospital with COVID-19. The United Kingdom has also approved it, while it is under review in Europe.
“WHO cautions in order not to exacerbate health inequity and limited availability of the therapy, patients who are non-severe and at higher risk for hospitalisation be treated and those that are severe or critical with seronegative status (those who have not developed natural antibodies against COVID-19 determined through accurate rapid tests) be treated; as these two patient groups are the patients that stand to benefit most from the treatment,” the statement said.
The health agency urged Regeneron, which holds the patent, to lower the drug’s price and work on equitable distribution worldwide. It should also share technology to allow for the manufacturing of biosimilar versions, the WHO added. Swiss drugmaker Roche is working in partnership with Regeneron to produce the antibody treatment.
Campaigners and public health experts have been urging pharmaceutical companies to lower prices and share intellectual property to ensure coronavirus treatments and vaccines, whose development is often funded by taxpayers, are available to those who need them most regardless of where they live.
‘Lives before profits’
As the WHO recommendation was announced, Medecins Sans Frontieres (MSF or Doctors Without Borders) urged Regeneron to make casirivimab and imdevimab available at a reasonable price, and stop enforcing patents, especially in low- and middle-income countries.
“It is simply not fair that people living in low and middle-income countries cannot access new COVID-19 treatments that can decrease the risk of death because of pharmaceutical companies’ monopolies and wishes for high returns,” Dr Elin Hoffmann Dahl, Infectious Disease Advisor, MSF Access Campaign, said in a statement.
“Casirivimab and imdevimab were only conditionally recommended for COVID-19, but Regeneron has already begun applying for patents. Regeneron should instead set an example for all manufacturers of monoclonal antibodies by putting people’s lives before profits. People everywhere need affordable, sustainable access to lifesaving drugs in this pandemic, as well as in the future.”
The treatment belongs to a class of drugs called monoclonal antibodies, which have been on the market for decades for many other diseases, including cancers. Each one is tailored to target a particular disease.
The antiviral cocktail has been priced at $820 in India, $2,000 in Germany and $2,100 in the US, with patent applications filed in at least 11 low and middle-income countries, MSF said, noting that the company had developed the treatment with “significant” public funding and that the manufacturing cost for monoclonal antibody drugs was estimated to be less than $100 a gram when produced at scale.
The WHO said UNITAID, an international health agency, was negotiating with Roche for lower prices and equitable distribution across all parts of the world. It is also in discussions with the company for a donation and distribution of the drug through UNICEF, following an allocation criteria set by WHO, it said.
Regeneron said it was only responsible for pricing in the US and that Roche was responsible for commercial decisions, including pricing, outside the US.