Regeneron’s Ebola treatment given US priority review

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Panuwat Sikham)
(Image: Getty/Panuwat Sikham)

Related tags Regeneron Ebola Coronavirus COVID-19

Regeneron’s triple antibody treatment for the Ebola virus has been provided US FDA priority review to speed regulatory action.

The company announced that the US Food and Drug Administration (FDA) had approved for priority review its biologics license application for REGN-EB3.

The treatment is a triple antibody cocktail treatment for the Ebola virus infection, which the company moved through the clinic with the aid of funding​ from the Biomedical Advanced Research and Development Authority (BARDA).

In November of last year, Regeneron was able to publish the results of a clinical trial showing that REGN-EB3 met a pre-specified superiority threshold on preventing death compared to standard of care.

As a result of the cocktail treatment’s efficacy, the trial was stopped early in August 2019. At the time, Neil Stahl, EVP of R&D at Regeneron, stated that it showed a ‘significant survival advantage’ and the company would continue to provide the treatment through an extension trial, as well as by compassionate use protocol.

The data showed that, of those given REGN-EB3 in the trial, 66.5% were alive at day 28 of the study, compared to 48.7% given standard treatment.

A target action date of October 25, 2020, has been set by the FDA on the potential treatment.

The treatment could become one of a number of tools that have been developed to combat the spread of the Ebola virus, after Merck, known as MSD outside of North America and Mexico, received approval​ from both the FDA and European Medicines Agency for its vaccine.

Reaching this point, took years of development​ and it is hoped that the lessons learnt during this period can aid in the creation of a vaccine for the novel coronavirus pandemic.

In its announcement on the priority review, Regeneron noted that the VelociSuite technology, used in the development of REGN-EB3, could also be turned against COVID-19. An existing treatment​ in the company’s portfolio is already being tested in late-stage trials for patients with the coronavirus.

Related topics Markets & Regulations Pipelines

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