(Reuters) – Europe’s drugs regulator said on Friday its safety panel found no evidence that Gilead’s remdesivir caused kidney problems in some COVID-19 patients.
Remdesivir, sold under the brand name Veklury, was conditionally approved in Europe in July for treating COVID-19 in adults and adolescents with pneumonia requiring oxygen support.
The European Medicines Agency (EMA) said to arrive at the conclusion the panel (PRAC) had assessed data provided by the U.S.-based drugmaker, analyses of reported adverse reactions, data from trials and published work on COVID-19 patients with acute kidney injury. bit.ly/2Z8PDyK
Separately, the PRAC also said it was not yet clear if there was any connection between remdesivir and reports of sinus bradycardia – or slow heartbeat – in COVID-19 patients, and started a new assessment for the same.
PRAC started an in-depth evaluation of all available data after Italy’s regulator raised concerns about 11 cases of sinus bradycardia in patients who had received remdesivir, the EMA said.
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