EMA starts evaluating COVID-19 medicine

RoActemra is considered a potential treatment for COVID-19 because of its ability to block the action of interleukin-6, a substance produced by the body’s immune system in response to inflammation, which plays an important role in COVID-19.   

EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of the data submitted in the application, including results from four large randomised studies in patients hospitalised with severe COVID-19, to decide whether the extension of indication should be authorised.

The CHMP's opinion, together with any requirements for further studies and additional safety monitoring, will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

EMA will communicate on the outcome of its evaluation, which is expected by mid-October unless supplementary information is needed.

About RoActemra

RoActemra is a medicine used to treat:

• adults with severe rheumatoid arthritis that is getting worse in patients who have not been previously treated with a medicine called methotrexate;
• adults with moderate to severe active rheumatoid arthritis whose previous treatments with disease modifying antirheumatic drugs (DMARDs), such as methotrexate or medicines known as tumour necrosis factor (TNF) blockers, have not worked well or were not tolerated;
• children from 1 year of age with active systemic juvenile idiopathic arthritis in whom other treatments (with anti-inflammatory medicines called NSAIDs and corticosteroids) have not worked well enough;
• children from 2 years of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough.

RoActemra is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate.

RoActemra is also used to treat adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen.

RoActemra can also be used in adults and children from 2 years of age for the treatment of severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure). CRS is a side effect of certain cancer treatments and RoActemra is used for CRS caused by chimeric antigen receptors (CAR) T-cell medicines.

RoActemra contains the active substance tocilizumab.

RoActemra was first authorised in the EU in 2009. More information about the medicine is available on the EMA website.