EMA sets 12 March J&J vaccine meeting; Celltrion's mAb gets Article 5(3) review

Regulatory NewsRegulatory News | 02 March 2021 |  By 

The European Medicines Agency (EMA) has announced an extraordinary meeting of its human medicines committee (CHMP) to evaluate the COVID-19 vaccine developed by Janssen, a Johnson & Johnson division. The aim of the 11 March meeting will be to “conclude the evaluation, if possible.”
The US Food and Drug Administration issued an emergency use authorization for the one-shot adenovirus vaccine on 27 February after its vaccines advisory committee voted unanimously that the benefits outweighed the risks of authorizing the vaccine. Janssen’s COVID-19 vaccine, which participated in the US Operation Warp Speed vaccine accelerator program, showed efficacy figures topping 80% in protecting against severe and critical COVID-19 in global clinical trials conducted in places such as South Africa where concerning variants predominate. It was 100% effective in preventing hospitalizations. (RELATED: Updated: FDA issues EUA for J&J's one-shot COVID vaccine, Regulatory Focus 26 February 2021)
On Tuesday, EMA also announced that it will review the monoclonal antibody regdanvimab, sponsored by Celltrion, to support individual national authorities’ decisions on use of regdanvimab before European Commission marketing authorization.
Emer Cooke, executive director of EMA, directed CHMP to take up an Article 5(3) review of Celltrion’s monoclonal antibody after discussion with the COVID-19 pandemic task force, according to the announcement of the review. CHMP will issue its scientific opinion “within the shortest possible timeframe.”
Regdanvimab is an intravenously infused monoclonal antibody that may help prevent progression to severe COVID-19 in outpatients with milder illness and do not require supplemental oxygen; it is under review for patients who are at high risk for developing severe disease or requiring hospitalization.
The Article 5(3) review is being conducted in addition to the ongoing rolling review of regdanvimab for conditional marketing authorization. EMA previously issued Article 5(3) opinions during the pandemic for the combination of the monoclonal antibodies casirivimab and indevimab. These two Regeneron-sponsored antibodies are also undergoing rolling review. CHMP also issued a favorable Article 5(3) opinion to the use of dexamethasone for patients with COVID-19 requiring supplemental oxygen or mechanical ventilation.
EMA extraordinary meeting announcement
EMA Article 5(3) announcement


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Tags: coronavirus, EMA, EU

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