(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.
Reporting by Tanishaa Nadkar in Bengaluru; Editing by Shinjini Ganguli
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