FDA Revokes HCQ EUA

An overview of FDA drug pipeline news from the past week.

FDA Issues EUA for COVID-19 Predictive Analytics Platform

JUN 16, 2020 | GRANT M. GALLAGHER

Clinicians and AI researchers from CLEEW Med announced today that the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the firm’s CLEWICU system.

"Healthcare providers need more than simple analytics. Systems need to integrate into the provider's workflow, offering ease of use and actionable data. The CLEWICU platform is designed to enable healthcare providers to monitor patient predicted risk levels across all units in real-time allowing for smart decision making about clinical resource allocation, ensuring prompt, proactive and efficient patient care," said Gal Salomon, CLEW CEO.

CLEWICUE uses predictive screening information to identify patients at increased risk of being diagnosed with respiratory failure or hemodynamic instability, common complications in severe coronavirus disease 2019 (COVID-19.)

The technology deploys AI-based algorithms that use machine-learning to identify respiratory failure and/or hemodynamic instability. The tool has potential implications for resource management, given identification of likely severe cases can be done hours in advance. This allows for further evaluation and, potentially, early intervention.

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FDA Revokes Emergency Authorization for Chloroquine, Hydroxychloroquine

JUN 15, 2020 | KEVIN KUNZMANN

The US Food and Drug Administration (FDA) has revoked the Emergency Use Authorization (EUAs) for hydroxychloroquine and chloroquine in treating coronavirus 2019 (COVID-19).

The decision comes with context in a letter written by Denis M. Hinton, chief scientist of the FDA, to the Biomedical Advanced Research and Development Authority (BARDA) on Monday morning. BARDA Deputy Assistant Secretary and Director of the Medical Countermeasure Programs Gary L. Disbrow, PhD, originally wrote the FDA requesting the 2 malaria drugs be revoked of their EUAs on the basis of continuously evolving public health response information.

“We now believe that the suggested dosing regimens for [chloroquine] and [hydroxychloroquine] as detailed in the Fact Sheets are unlikely to produce an antiviral effect,” Hinton wrote. “Earlier observations of decreased viral shedding with [the treatments] have not been consistently replicated and recent data from a randomized controlled trial assessing probability of negative conversion showed no difference between [hydroxychloroquine] and standard of care alone. “

Hinton also noted that current US treatment guidelines do not recommend either drug’s use in patients hospitalized with COVID-19 outside of clinical trials. These guidelines now include those of the National Institutes of Health (NIH), she added.

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