(Reuters) The recommendation issued Monday by the European Union’s drug regulator was to extend RoActemra’s usage for COVID-19 patients receiving systemic steroids and who require oxygen support or mechanical ventilation.
The European Medicines Agency (EMA) said that its human medicine committee analyzed data from a study that involved more than 4,000 hospitalized adults, and concluded that the medication’s benefits outweigh the risk for these patients. The EMA’s approval follows the fact that Europe has seen at minimum 75 million cases of coronavirus as the world braces for the new Omicron variant.
The formal approval process is left to the European Commission, which typically is a follow-up to EMA recommendations.
RoActemra also known chemically as tocilizumab, is a rheumatoid arthritis medication that was approved in June by the U.S. regulator of drugs for COVID-19 emergency use in patients in hospitals who require oxygen.
The World Health Organization, which had also recommended the drug based on promising clinical trial results, has been working with Roche to get the drug to places where it is not yet being used.
In August, the WHO had called on Roche to ensure a fair distribution of RoActemra to treat COVID-19 patients, after the drug supply had run low due to an increase in cases.
Roche reported unprecedented demand for the drug in the same month with orders well above 400% of preCOVID levels.
Content Source: https://www.medscape.com/viewarticle/964253?src=rss
