Kineret under review by EMA for some COVID patients

Regulatory NewsRegulatory News | 19 July 2021 |  By 

The European Medicines Agency has begun a new evaluation of an immunosuppressive drug to treat certain patients with COVID-19.
The agency announced Monday that it is reviewing an extension of indication for Kineret (anakinra, Swedish Orphan Biovitrum AB), to treat people with COVID-19 pneumonia at risk of developing severe respiratory failure. The human interleukin-1 (IL-1) antagonist was first authorized for use in the EU in 2002 and is currently authorized for the treatment of rheumatoid arthritis, as well as some autoinflammatory periodic fever syndromes.
The IL-1 blocker interrupts “a chemical messenger involved in immune processes that lead to inflammation,” EMA noted in announcing its decision to evaluate Kineret. “It is thought that this could also help reduce the inflammation and tissue damage associated with COVID-19.”
The application for Kineret’s extension of indication will be reviewed by CHMP, EMA’s human medicines committee, with a decision expected by October 2021 “unless supplementary information is needed.” Kineret’s marketing authorization holder submitted available data from two ongoing clinical studies of Kineret in adult patients hospitalized which COVID-19. The committee may ask for more studies or specify more safety monitoring before forwarding its recommendation to the European Commission (EC).
EMA also began evaluating Eli Lilly’s Olumiant (baricitinib) in April 2021, assessing Lilly’s request to expand Olumiant’s indication to treat patients with COVID-19 who are hospitalized and require supplemental oxygen. Olumiant, a Janus kinase inhibitor, also has anti-inflammatory properties and is currently authorized to treat some patients with rheumatoid arthritis and atopic dermatitis.
Several other novel therapies are currently rolling review by EMA for the treatment of COVID-19. This accelerated review process allows applicants to submit data as they become available. These include Lilly’s combination of the antibodies bamlanivimab and etesevimab; Celltrion’s reganvimab; Regeneron and Roche’s REGN-COV2, a combination of casirivimab and imdevimab; and sotrovimab, being developed by GlaxoSmithKline and Vir Biotechnology, Inc. (RELATED: EC issues first COVID therapeutics portfolio, Regulatory Focus 29 June 2021)
Gilead’s antiviral Veklury (remdesivir) received a conditional marketing authorization in the EU for the treatment of some patients with COVID-19.
In May 2021, the EC set forth its strategy on COVID-19 therapeutics, highlighting flexible approaches such as rolling review that allow EMA “to check data from ongoing studies as they become available, before a formal application for the (conditional) marketing authorisation is submitted.” That strategy also includes the use of conditional marketing authorizations, “based on a less comprehensive dataset than would normally be the case, subject to a positive benefit-risk balance.” Individual member states can also use mechanisms such as compassionate use and emergency use authorizations to provide early access to medicines not yet authorized.
No EU-wide emergency use authorization mechanism currently exists, but a legislative proposal “that would ensure an even faster access to medicinal products” during public health emergencies is also under consideration by the EC.


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