EC issues first COVID therapeutics portfolio

Regulatory NewsRegulatory News | 29 June 2021 |  By 

As part of its strategy for COVID-19 therapeutics, the European Commission (EC) on Tuesday released a portfolio of the initial five therapeutics being considered for authorization for the treatment of COVID-19 patients.
Four of the candidate therapeutics are monoclonal antibodies in consideration under the European Medicines Agency’s rolling review process. The fifth therapeutic being considered, Eli Lilly’s Olumiant (baricitinib), is an orally administered immunosuppressant that has a marketing authorization in the EU for rheumatoid arthritis and atopic dermatitis indications. Eli Lilly has applied for authorization of an extension of indication for the drug to treat COVID-19.
“Today we are taking the first step towards a broad portfolio of therapeutics to treat COVID-19,” said Stella Kyriakides, EC’s Commissioner for Health and Food Safety, in a press release announcing the portfolio. “Whilst vaccination is progressing at increasing speed, the virus will not disappear and patients will need safe and effective treatments to reduce the burden of COVID-19.”
The announcement comes as the EC moves toward meeting a strategic goal of authorizing “at least” three new COVID-19 therapeutics by October 2021, with “possibly two more” coming by the end of the year, according to the announcement.
A question-and-answer document was also released Tuesday outlining the rationale for selection of the therapeutics and detailing how the release of the first portfolio fits into the broader EU COVID-19 strategy. “The initial list of five therapeutics is a snapshot of the most advanced COVID-19 therapeutics in terms of development,” according to the Q-and-A document.
The EC is also casting a broader net to consider therapeutics that retain efficacy in the face of an increasing number of SARS-CoV-2 variants. The goal is to develop a list of “at least” 10 therapeutics, and then to continue looking at the development pipeline to stay abreast of challenges posed by virus variants.
Six monoclonal antibodies that have been newly developed to treat COVID-19 are under rolling review by EMA. Two antibodies, Eli Lilly’s banlanivimab and etesevimab, are under rolling review as an antibody “cocktail” designed to be administered together.
EMA is also considering Regeneron and Hoffman-La Roche’s cocktail of casirivimab and imdevimab under the rolling review mechanism, by which the agency receives and reviews non-clinical and clinical data as they are made available by the applicant, speeding the course to marketing authorization for certain COVID-19 therapeutics. (RELATED: EMA reviewing data on four COVID monoclonal antibodies, Regulatory Focus 04 February 2021)
Regdanvimab, Celltrion’s offering, is under rolling review as monotherapy, as is sotrovimab from GlaxoSmithKline and Vir Biotechnology. The Q-and-A document explains that the inclusion of these monoclonal antibody candidates, all of which target the SARS-CoV-2 virus spike protein via intravenous infusion, are based on “promising preliminary results from clinical studies.”
“The five products are in an advanced stage of development and have a high potential to be among the three new COVID-19 therapeutics to receive authorization by October 2021,” the target date set by the group working on the EU Strategy on COVID-19 Therapeutics, according to the press release. The candidates will benefit from regulatory flexibilities including the potential for conditional marketing authorizations and more flexibility in meeting labeling and packaging requirements.
“Our goal is clear, we aim to identify more front-runner candidates under development and authorize at least three new therapeutics by the end of the year,” said Kyriakides.
All candidates in the portfolio save baricitinib have already received favorable Article 5(3) reviews from EMA’s human medicines committee (CHMP) and can be used to treat patients with COVID-19. The steroid drug dexamethasone has also been endorsed by EMA for use in patients requiring supplemental oxygen or mechanical ventilation, after Article 5(3) review. The antiviral remdesivir, marketed as Veklury by Gilead, has received a conditional marketing authorization for use in the EU to treat COVID-19.
In the US, remdesivir has been approved to treat adult and older pediatric COVID-19 patients. Olumiant and Veklury have an emergency use authorization (EUA) for use in combination, as does the combination of casirivimab and imdevimab. Bamlanivimab’s EUA for standalone use was revoked by FDA in the face of decreased efficacy against variant virus strains. It has an EUA for combination use with etesivimab, though distribution was paused 25 June. Sotrovimab and Actemra (tocilizumab, Genentech) each have EUAs for standalone use in specific populations of COVID-19 patients.
European Commission


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