FOSTER CITY -
Veklury is currently available in the
The filing is supported by data from two randomized, open-label, multi-center Phase 3 clinical studies of Veklury conducted by Gilead and the Phase 3 randomized, placebo-controlled study of Veklury conducted by the
'Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations,' said
Veklury has been approved by multiple regulatory authorities around the world, including in the
About Veklury
Veklury (remdesivir) is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of SARS-CoV-2 infection, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies.
Important Information about Veklury in
In
Veklury is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of Veklury for the treatment of COVID-19 have not been established. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process.
There are limited clinical data available for Veklury. Serious and unexpected adverse events may occur that have not been previously reported with Veklury use. Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of Veklury. The use of Veklury is contraindicated in patients with known hypersensitivity to remdesivir. Transaminase elevations have been observed in healthy volunteers and patients with COVID-19 in clinical trials who received Veklury. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with Veklury; additionally monitor serum chemistries and hematology daily during therapy. Do not initiate Veklury in patients with ALT 5x ULN or with an eGFR
(C) 2020 Electronic News Publishing, source