FDA looks to accelerate plasma therapies for coronavirus

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Malija)
(Image: Getty/Malija)

Related tags: US FDA, Plasma, Coronavirus, COVID-19

US FDA looks to coordinate and speed up the development of blood-derived therapies to treat patients with COVID-19.

It was announced last week​ that the first patient in the US had received a transfusion of plasma donated from a patient who had recovered from COVID-19.

Now, the US Food and Drug Administration (FDA) is aiming to facilitate greater access to this type of therapy across the country.

In particular, the agency is looking to aid the investigation of convalescent plasma, used in this first case, and also hyperimmune globulin, which are both antibody-rich blood products donated by those who have recovered from the novel coronavirus.

Though it is based on a limited pool of data, the FDA suggested that both forms of treatment ‘may have benefit’ in the treatment of COVID-19, after such signs were seen when utilized in China.

The first case of such treatment usage in the US was allowed through an emergency investigational new drug application, while the agency is also accelerating the setting up of clinical trials at academic institutions to determine the safety and efficacy of convalescent plasma.

In addition, the FDA specified that it had worked with the Mayo Clinic and the American Red Cross, alongside the Biomedical Advanced Research and Development Authority (BARDA), to develop access for patients to receive convalescent plasma in areas where there are no institutions with clinical trials.

In regard to the development of hyperimmune globulin, the FDA is coordinating a study that would be conducted by the National Institutes of Health (NIH).

The agency noted that it would use ‘regulatory flexibility’ in making such medical treatments available to patients.

In terms of how rapidly patients could start seeing these treatments, Alex Azar, secretary of the department of Health and Human Services, said, “Thanks to the hard work of FDA staff, scientists and physicians elsewhere, and support from NIH and BARDA, patients will be able to benefit from these promising new options in the coming weeks.”

Further than this, the FDA encouraged people who have fully recovered from COVID-19 for at least two weeks to consider donating plasma.

Related topics: Markets & Regulations, Pipelines

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