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Remdesivir is not approved by the FDA nor licensed or approved anywhere in the world.
The investigational drug remdesivir demonstrated that a 10-day treatment course achieved similar improvement in the clinical status of patients as a 5-day treatment course. Announced today by Gilead Sciences, these topline results were culled from an open-label phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the antiviral in hospitalized patients with severe manifestations of the coronavirus disease 2019 (COVID-19).1
No new safety signals were identified with remdesivir across either treatment group, according to Gilead.1
Remdesivir is not approved by the FDA nor licensed or approved anywhere in the world. The drug has not yet been demonstrated to be safe or effective for the treatment of COVID-19.1,2
However, remdesivir, a nucleotide analog with broad-spectrum antiviral activity, has demonstrated activity against MERS and SARS, indicating that it may have potential activity against COVID-19.2
Due to the COVID-19 pandemic, the FDA designatedremdesivir for ‘compassionate use’in March 2020,allowing patients with serious or life-threatening cases of the virus to have access to the drug.2Remdesivir has also been granted the investigational antiviral Orphan Drug status by the FDA.3
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping to inform whether remdesivir is a safe and effective treatment for COVID-19, and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, in a prepared statement.1
A version of this article was originally published by Pharmacy Times. Read the full article atPharmacyTimes.com.