NETHERLANDS – The European Medicines Agency (EMA) has recommended extending the use of Roche’s RoActemra arthritis drug for adult COVID-19 patients receiving systemic steroid treatment and those requiring oxygen support or mechanical ventilation.
The European Medicines Agency (EMA) stated that its human medicines committee reviewed data from a large study involving over 4,000 hospitalized adults and concluded that the benefits outweighed the risks for these patients.
The EMA’s approval comes after Europe has seen at least 75 million coronavirus cases, as the world prepares for the new Omicron variant.
The European Commission, which typically follows EMA recommendations, is in charge of formal approval.
RoActemra, also known as tocilizumab, is a rheumatoid arthritis drug that was approved by the US Food and Drug Administration in June for COVID-19 emergency use in hospitalized patients who require oxygen.
The World Health Organization, which had previously recommended the drug based on promising clinical trial data, has been collaborating with Roche to bring the drug to areas where it is not yet in use.
The WHO had called on Roche in August to ensure equitable distribution of RoActemra to treat COVID-19 patients after the drug supply had run low due to rising case numbers.
The same month, Roche reported unprecedented demand for the drug, with orders exceeding 400 percent of pre-COVID levels.
In August, the European Medicines Agency recommended two COVID-19 antibody therapies, one from American-Swiss partners Regeneron-Roche and another from South Korea’s Celltrion, as the region sought to strengthen its defense against rising cases.
The European Commission’s approval was the first for a COVID-19 treatment on the continent since Gilead’s remdesivir last year.
The EMA’s human medicines committee approved Regeneron-Ronapreve Roche’s antibody cocktail for treating adults and children over the age of 12 with COVID-19 who do not require oxygen support and are at high risk of severe disease. Regkirona by Celltrion was only recommended for adults with similar conditions.
Still on Covid-19 treatment front, Novartis has announced it is developing pan-coronavirus disease oral treatment.
Novartis hopes to continue playing a role in the development of COVID-19 treatments, with research for a pill that could work against all coronaviruses, not just the one that causes COVID-19, according to CEO Vas Narasimhan.
When asked if Novartis had been on the sidelines during the pandemic, the head of the Swiss drugmaker pointed to Novartis’ manufacturing support to COVID-19 vaccine and drug makers in an interview following his recent presentation at Total Health, as Reuters reports.