EU Set to Authorize New Covid-19 Medicines by October

Health | May 7, 2021, Friday // 10:49|  views

In its Therapeutics Strategy, adopted on Thursday, the Commission says that vaccination rates are increasing across the EU, but therapeutics are vital to treat those people who are still falling ill and reduce the rate of acute and severe Covid-19. It also includes the treatment of so-called ‘long Covid’.

Authorizing three new therapeutics to treat Covid-19 by October and possibly two more by end of the year are among the targets set in the strategy.  This will be ensured by development of flexible regulatory approaches to speed up the assessment of therapeutics. The only drug for Covid authorized so far is Remdesivir.

Saying that vaccinations save lives, but they cannot yet eradicate Covid-19, EU Commissioner for Health and Food Safety, Stella Kyriakides, pointed out that the EU needs a strong push on treatments to limit the need for hospitalization, speed up recovery times, and reduce mortality.

By October, we will develop and authorize three new effective Covid-19 therapeutics that can have the potential to change the course of the disease, she explained. “We will do so by investing in research and innovation, the identification of new promising medicines, ramping up production capacity and supporting equitable access,” the Commissioner added.

The strategy’s scope takes in the complete lifecycle of medicines - from research, development and manufacturing to procurement and deployment.

On research, development and innovation side, the strategy foresees investing €90m in population studies and clinical trials to establish links between risk factors and health outcomes.

A ‘therapeutics innovation booster' to upkeep the most promising therapeutics from preclinical research to market authorization will be set up by July this year.

It 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 strategy plans.

For swift approval of clinical trials generating better, high-quality safety data will be spent €5m under the EU4Health program. EU countries will receive financial support of €2m under the same program for expedited and coordinated assessments to facilitate approval of clinical trials.

It also envisages exploring how to support developers of therapeutics to build capacity to produce high-grade material for clinical trials.

Very important aspect in the plan is scanning for candidate therapeutics and for this purpose will be invest €5m to map therapeutics and diagnostics to analyze development phases, production capacities and supply chains, including possible bottlenecks.

By June will be drew up a list of 10 potential therapeutics including the 5 most promising.

When it comes to supply chains and delivery of medicines, the strategy suggests €40mto be funded in preparatory action to support flexible manufacturing and access for Covid-19 therapeutics under the EU Fab project.

Seven rolling reviews of promising therapeutics will be launched by end-2021.

 Concerning joint procurement and financing, new contracts will be signed for the purchase of authorized therapeutics by the end of the year and  faster access to medicines with shorter administrative deadlines will be secured.

The strategy also reinforces engagement for the therapeutics pillar of the Access to Covid-19 Tools Accelerator and boosts ‘OPEN' initiative for international collaboration.



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Tags: EU, Stella Kyriakides, COVID-19, new medicines, authorization


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