CHMP to Assess Extended Indication of Kineret for COVID-19

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) is assessing data to evaluate whether Kineret (anakinra) can be used as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

Kineret is an immunosuppressant that has been authorized for use in the European Union for a number of inflammatory conditions since March 2002. It is believed that the API, anakinra, in Sobi’s Kineret could help reduce the inflammation and tissue damage associated with COVID-19. Anakinra works by blocking the activity of interleukin 1, which is a chemical messenger involved in immune processes that lead to inflammation.

Data from two ongoing clinical studies that are investigating the safety and efficacy of Kineret in adult patients hospitalized with COVID-19 are being evaluated by the CHMP. The committee’s opinion on whether or not Kineret’s indication can be extended will be forwarded to the European Commission, which will issue the final decision on marketing authorization for the European Union.

The outcome of the evaluation, which is expected to be released by October 2021, will be published by EMA.

Source: EMA