Regulatory response: FDA authorizes emergency 2019-nCoV diagnostic, EMA activates emergency plan

FDA and EMA each unveiled measures Tuesday to combat the 2019-nCoV outbreak, with the U.S. agency issuing emergency use authorization for a diagnostic and its European counterpart activating its emerging health threats management plan.

Both come the week after WHO declared the coronavirus infection a Public Health Emergency of International Concern and HHS deemed it a public health emergency (see “U.S. Declares 2019-nCoV a Public Health Emergency” and “WHO Declares Coronavirus Public Health Emergency”).

There are no approved diagnostics, vaccines or treatments for 2019-nCoV acute respiratory disease.

Under FDA’s EUA, the 2019-nCoV Real-Time RT-PCR Diagnostic Panel from the U.S. Centers for Disease Control and Prevention’s may be used for patients meeting CDC’s criteria for 2019-nCoV testing. The test works by amplifying and detecting regions of the virus’ genome from respiratory secretions including nasal and oral swabs. FDA is working with other diagnostics developers to accelerate their programs and EUA requests.

Separately, as part of its activated plan for managing emerging health threats, EMA is urging those working on preventative or therapeutic products against the new coronavirus to discuss their development strategies, including evidence generation, with the agency.

EMA’s tools to spur drug development for 2019-nCoV acute respiratory disease include its PRIority MEdicines (PRIME) scheme, accelerated assessment and conditional marketing approval.

The plan also aims for regular meetings with experts on the virus; coordination with European and global bodies including WHO, the European Commission and the European Centre for Disease Control; and communication with stakeholders including patients and healthcare providers.

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