EU Regulator Backs Tocilizumab for Treating Severe COVID-19

By Reuters Staff

December 07, 2021

(Reuters) - The European Union's drug regulator on Monday recommended extending the use of Roche's RoActemra arthritis drug for adult COVID-19 patients on systemic treatment with steroids and those who need oxygen support or mechanical ventilation.

The European Medicines Agency (EMA) said its human medicines committee evaluated data from a main study involving over 4,000 hospitalised adults, and concluded that the medicine's benefits outweigh the risks for these patients. The EMA's endorsement comes after Europe crossed at least 75 million coronavirus cases as the world braces for the new Omicron variant.

Formal approval is up to the European Commission, which typically follows EMA recommendations.

RoActemra, chemically known as tocilizumab, is a rheumatoid arthritis drug that was approved in June by the U.S. drug regulator for COVID-19 emergency use in hospital patients who need oxygen.

The World Health Organization, which had also recommended the drug after promising clinical trial data, has been working with Roche to get the drug to places where it is not yet in use.

In August, the WHO had called on Roche to ensure fair distribution of RoActemra to treat COVID-19 patients after the drug supply had run low due to rising cases.

Roche flagged unprecedented demand for the drug the same month, with orders well over 400% of pre-COVID levels.

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