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30th October 2020
The approval requires that remdesivir is only used in a hospital or healthcare setting capable or providing acute care which is comparable to hospital care. This new approval does not however, include the entire population that was originally included via the emergency use authorisation (EUA) issued on 1 May 2020. In order to allow continued use in paediatric patients the EUA was amended for use only in laboratory confirmed COVID-19 cases for patients weighing 3.5 to less than 40kg less or hospitalised children under 12 years of age weighing at least 3.5kg. However, the FDA makes clear that this is NOT an approved use of the drug and that this authorisation is only temporary and could be revoked.
The approval in adults was based on three randomised clinical trials which showed that treatment with remdesivir lead to clinically meaningful improvements across multiple outcomes compared to placebo. For instance, in the most recent ACTT-1 trial, published in the New England Journal of Medicine, remdesivir significantly improved time to recovery by 5 days and reduced disease progression among patients requiring oxygen. It also showed an improved time to recovery among patients not requiring oxygen in the SIMPLE-Moderate trial conducted in hospitalised patients. Moreover, adverse effects with remdesivir were similar to placebo.
Remdesivir was approved under the early access to medicines scheme in the UK in May 2020.
FDA News release. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19