EC strategy aims for 3-5 new COVID therapeutics by year end

Regulatory NewsRegulatory News | 06 May 2021 |  By 

To support the development of therapeutics for COVID-19, the European Commission on Thursday announced a new strategy intended to bring at least three to five new COVID-19 therapeutics to market this year.
The strategy, which includes more than €140 million in funding, aims to streamline the development of promising new medicines and ensure their speedy rollout across the EU, complementing the strategy the Commission deployed for COVID-19 vaccines last year. (RELATED: EC lays out strategy for effective COVID vaccine rollout, Regulatory Focus 16 October 2020).
In announcing the new strategy, EU Health Commissioner Stella Kyriakides expressed confidence in the EU’s vaccine rollout, noting that the 27-member state bloc is on track to vaccinate 70% of its adult population in July.
“While this is of course very positive news, vaccines cannot be our only response to COVID-19 … infections are still high in many parts of Europe. People continue to be infected and fall ill and among those who recover from COVID-19, we know that many suffer from what is known as ‘long COVID’, experiencing symptoms of fatigue, difficulties to sleep, concentration issues weeks, even months after the infection is gone,” she said.
There are currently four authorized COVID-19 vaccines in the EU but just one authorized therapeutic, Gilead Sciences’ Veklury (remdesivir). However, the European Medicines Agency (EMA) has issued four recommendations on the use of therapeutics to facilitate their use at the national level prior to their EU-wide authorization via so-called Article 5(3) reviews.
“Our strategy on COVID-19 therapeutics aims to change this situation,” Kyriakides said. “It is crucial that alongside vaccines, we also step up our work on therapeutics, and bring the different strands of our work together to speed up recovery, reduce hospital stays and save lives.”
Tenets of the strategy include a funding population and clinical studies to identify risk factors and health outcomes related to COVID-19; speeding the approval of clinical trials; scanning for candidate therapies to identify the most promising candidates; and investing in manufacturing and supply chains.
By July 2021, the strategy aims to set up a “therapeutics innovation booster” to support promising therapeutics from the preclinical stage through authorisation, with the goal of bringing at least three new therapeutics to market by October and two more by the end of the year.
The innovation booster “will build on current initiatives and investments in therapeutic development, working in a close cooperation with the European Health Emergency Preparedness and Response Authority (HERA) preparatory action on mapping therapeutics,” the Commission said.
The strategy will also support for joint procurement and financing to ensure the medicines can be made available across the EU more quickly.
The Commission said its next steps will be to identify a portfolio of 10 potential therapeutics by June 2021 before sifting out the most promising five candidates and to begin organizing matchmaking events with manufacturers to ensure production capacity for successful candidates.
European Commission


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Tags: coronavirus, drugs, EU

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