EMA, FDA and WHO prep for new coronavirus treatments, IVDs

Following the World Health Organization’s (WHO) determination last week that the spread of the novel coronavirus (2019-nCoV) from Wuhan, China is a public health emergency of international concern, the European Medicines Agency (EMA), FDA and WHO have taken various precautions and prepared for new medicines, vaccines and in vitro diagnostics (IVDs).

FDA on Tuesday issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel for the “presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals who meet CDC criteria for 2019-nCoV testing.”

To date, this test has been limited to use at CDC laboratories, but FDA said today’s authorization allows the use of the test at any CDC-qualified lab nationwide.

EMA also said Tuesday that it is ready to support drug developers with all available regulatory tools (i.e., scientific advice, the PRIME scheme, the accelerated assessment and conditional marketing authorization) to advance and expedite the development of ways to fight and prevent the spread of this virus.

“Developers working on medicinal products or vaccines that could be used for treatment or prevention of novel coronavirus 2019-nCoV infections are encouraged to contact the Agency and discuss their strategy for evidence generation as soon as possible. They can contact EMA by sending an email to 2019-nCoV@ema.europa.eu for initial discussions with EU regulators,” EMA said.

WHO on Tuesday said that there are now more than 20,000 cases of 2019-nCoV and 425 deaths. The death toll rose to 490 by Tuesday evening, according to the Chinese government.

Almost a dozen clinical trials are beginning to take shape in China, including one for a recombinase aided amplification (RAA) assay at a Beijing hospital, as well as one to test the efficacy and safety of the antiviral treatment arbidol in patients with 2019-nCoV.

The US Department of Health and Human Services (HHS), after declaring a public health emergency last Friday, said Tuesday that it’s working with Regeneron Pharmaceuticals to develop multiple monoclonal antibodies that could be used to treat 2019-nCoV. Other large biopharma companies are also working on treatments and vaccines, including Gilead Sciences, GlaxoSmithKline and Johnson & Johnson.

And the US Biomedical Advanced Research and Development Authority (BARDA) is providing a portal for companies and interested stakeholders to submit market research packages. FDA last week also outlined the product development process for combating this virus.

“Federal agencies are particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, or utilize a platform already approved by the U.S. Food and Drug Administration (FDA),” HHS said.

Meanwhile, FDA, which has canceled all staff travel to China, on Tuesday said it is aware that some blood establishments are considering donor education and/or donor deferral measures in response to 2019-nCoV. However, FDA said that respiratory viruses, in general, are not known to be transmitted by blood transfusion and there have not been any reported cases of transfusion-transmitted coronavirus.

“Routine blood donor screening measures that are already in place should prevent individuals with clinical respiratory infections from donating blood,” FDA says.

WHO also published its Emergency Use Listing (EUL) procedure to streamline the process by which new or unlicensed products can be used during public health emergencies. The EUL replaces the Emergency Use Assessment and Listing (EUAL) procedure, which was used during the West Africa Ebola outbreak of 2014-2016.

Editor’s note: Article update on 2/4/20 with more information about the EUA and the death toll in China.


RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.

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