The European Commission has signed a joint procurement framework contract for the supply of a newly developed COVID-19 therapeutic currently under rolling review by the European Medicines Agency (EMA).
The investigational monoclonal antibody therapy Sotrovimab, developed by the British pharmaceutical company GlaxoSmithKline in collaboration with VIR biotechnology, is part of the first portfolio of five COVID-19 therapeutics announced by the Commission in June 2021.
Signed on 27 July, the contract will provide the purchase of up to 220,000 treatments, involving 16 EU member states.
Sotrovimab can be used for the treatment of coronavirus patients with mild symptoms who do not require supplemental oxygen, but who are at high risk of developing severe cases of COVID-19.
Ongoing studies suggest that early treatment can reduce the number of patients that progress to more severe forms and require hospitalisation or admission to intensive care units.
“We are now delivering a second framework contract that brings monoclonal antibodies treatments to patients,” commented EU health commissioner Stella Kyriakides.
She added that, alongside vaccines, safe and effective therapeutics will play a pivotal role in Europe’s return to a new normal.
The first contract of this kind was signed in April with the Swiss pharma company Roche that, together with Regeneron, developed a cocktail of two monoclonal antibodies to block the infectivity of Sars-CoV-2.
Under the current framework contract with GlaxoSmithKline, member states can purchase sotrovimab if and when needed, once it has received either emergency use authorisation in the country who requested it or a marketing authorisation from the EMA.
The EU’s medicine agency gave a positive review of the use of the monoclonal therapy in an initial assessment published in May ahead of the more detailed assessment for marketing authorisation currently underway.
The Commission has concluded nearly 200 contracts for different medical countermeasures worth over €12 billion.
The target set under the COVID-19 therapeutics strategy is to have three new COVID-19 therapeutics authorised by October 2021 and possibly two more by the end of the year.
The strategy aims to reproduce the same joint procurement approach adopted in the vaccine strategy in July last year, allowing Europe to have a stronger effect compared to one-off uncoordinated actions.
The portfolio of five candidate therapeutics that are in an advanced stage of development and could soon be available to treat patients across the EU, was announced at the end of June.
Four of these therapeutics are monoclonal antibodies under rolling review by the EMA. Another one is an immunosuppressant, which has a marketing authorisation that could be extended to include the treatment of COVID-19 patients.
There should be new therapeutics added to the portfolio, as the Commission is said to be drawing up a portfolio of at least 10 potential COVID-19 therapeutics by October.
So far, the only COVID-19 treatment authorised in the EU is Remdesivir, an antiviral drug produced by the pharmaceutical company Gilead.
The Commission signed a €1 billion deal to buy 500,000 treatment courses of Remdesivir after granting conditional approval for the treatment in July.
[Edited by Gerardo Fortuna and Benjamin Fox]