EMA CHMP recommends granting approval for Roche’s therapy to treat Covid-19

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended EU marketing authorisation for Roche’s Actemra/RoActemra (tocilizumab) to treat adult Covid-19 patients.

If approved, the treatment is intended for patients who are taking systemic corticosteroids and need supplemental oxygen. These individuals also require mechanical ventilation.

An anti-interleukin 6 (IL-6) receptor biologic, Actemra/RoActemra is offered in intravenous and subcutaneous formulations to treat adults with moderate-to-severe active rheumatoid arthritis.

The European Commission (EC) will decide on the approval of Actemra/RoActemra soon.

The CHMP commenced an expedited analysis of the therapy in August and reviewed data from four clinical trials that enrolled more than 5,500 severe or critical Covid-19 patients.

Data from Phase III COVACTA, EMPACTA and REMDACTA trials led by Roche and the company-supported RECOVERY trial by the University of Oxford in the UK were analysed by the committee.

The totality of the clinical data showed that Actemra/RoActemra lowered mortality risk in individuals with severe or critical disease.

Roche Global Product Development head and chief medical officer Levi Garraway said: “As Covid-19 cases in Europe rise and with pressure on hospitals likely to increase, the need for effective treatments for those suffering most severely with Covid-19 could intensify.

“We are proud that the CHMP has recognised the potential of Actemra/RoActemra as we continue our efforts to bring treatment options to those most in need.”

Actemra/RoActemra received emergency use authorization (EUA) in the US and Ghana, provisional approval in Australia and is also recommended by the World Health Organization (WHO) to treat Covid-19.

In September, Indian company Hetero received emergency use approval from the Drugs Controller General of India to manufacture a generic version of tocilizumab.

In a separate development, Roche concluded the repurchase of 53.3 million bearer shares of the company from Novartis for $20.7bn.

Roche announced repurchase plans in November.