WHO and ‘Trump monoclonals’: “Guarantee fair doses and prices”

It is a combination of monoclonal antibodies and in October 2020 it ended up in the spotlight of the world because it was one of the therapies used to treat former US president Donald Trump, after the discovery of his positivity to Covid-19. Now the World Health Organization (WHO) updates its clinical care guidelines to include treatment and recommends Regeneron mix for two specific patient groups (currently the only monoclonal mix on the list drugs for which recommendations have been made). At the same time, however, the treatment that combines the casirivimab and imdevimab antibodies also becomes the subject of a heartfelt appeal by the WHO, which asks for action on several fronts to ensure that equal access is guaranteed. The main brakes? “Limited production” and “high price”. The combination has been recommended for patients with non-severe Covid-19 who are at higher risk of hospitalization and for patients who have already deteriorated or are in critical condition and are seronegative, i.e. have not developed antibodies. The update was defined by a working group, made up of international experts and patients, which deals with the development of the guidelines and the content is published in the journal ‘BMJ’. The recommendation for use to prevent severe disease in high-risk patients is based on new evidence from 3 not yet peer-reviewed studies showing that casirivimab and imdevimab are likely to reduce the risk of hospitalization and duration of symptoms in non-peer-reviewed patients. vaccinated, elderly, or immunosuppressed patients.The second recommendation is based on data from the Recovery study showing how casirivimab and imdevimab can reduce deaths (ranging from 49 fewer in 1,000 in the seriously ill to 87 fewer in critically ill) and need for mechanical ventilation in seronegative patients. “For all other Covid patients – reads Bmj – the benefits of this antibody treatment are unlikely to be significant”. WHO “welcomes the addition of another therapy to the global arsenal against Covid, but urges manufacturers and governments to address the” cost and availability issue “of the Regeneron antibody combination and ensure safety and security. correct handling of the medicine “, highlights the UN agency in a note. “Given the high cost and low availability of the therapy”, the global health initiative “Unitaid – informs WHO – is negotiating with Roche Pharmaceutical, which is currently producing the drug, for lower prices and fair distribution in all regions, especially in low- and middle-income countries. WHO is also discussing with the company a donation and distribution of the drug through Unicef, following an allocation criteria established by WHO “. In parallel, the agency UN for health has launched an appeal “to manufacturers who may wish to present their products for pre-qualification”, which “would allow for an acceleration of production and therefore greater availability of treatment and expanded access. Act partners -A “, the platform that deals with accelerating the availability of tools for the fight against Covid” are also working with the WHO on an equitable access framework for recommended therapies “. WHO is also calling for the sharing of technology to allow the production of biosimilar versions so that all patients who may need this treatment can access them. “In addition, there are feasibility issues related to the intended intravenous administration of the antibodies. : “In the outpatient setting, this can be a challenge – reads the note – and therefore subcutaneous administration may be an option at the lower dose”. WHO calls for a careful use of the treatment and reiterates the importance, “to in order not to exacerbate health inequalities and the limited availability of therapy “, that non-serious patients at high risk of hospitalization and serious or critically ill patients with seronegative status are treated (those who have not developed natural antibodies against Covid-19, was determined through accurate rapid tests), as these two patient groups are the patients who will benefit most from the treatment. “