The US Food and Drug Administration (FDA) has granted clearance to Gilead Sciences’ supplemental new drug application (sNDA) of Veklury (remdesivir) for use in Covid-19 patients.
This therapy is intended for use in patients with severe renal impairment including those on dialysis.
The latest announcement comes after the decision from European Commission to extend the use of Veklury for the treatment of patients with Covid -19.
With the updated information, renally-impaired patients are not required to undergo eGFR testing before or during treatment with Veklury.
The approval is based on data from a Phase I study and the Phase III randomised, double-blind, placebo-controlled, parallel-group, multicenter REDPINE trial. Both the studies demonstrated safety profile and pharmacokinetics of Veklury in these patients.
There were no new safety signals observed in both studies.
Gilead Sciences Clinical Research for Hepatitis, Respiratory and Emerging Viruses vice-president Anu Osinusi said: “The approval by the FDA of Veklury for the treatment of patients with renal impairment reflects the urgency to make this medicine available to these patients, and underscores the established safety profile for Veklury.
“Gilead is committed to discovering, developing and providing transformational therapies for Covid-19, including for the most vulnerable populations at risk of developing severe disease.”
In the US, Veklury is used to treat Covid-19 in both adults and paediatric patients who are 28 days and above and weigh a minimum of 3 kgs.
It is indicated for use in patients either hospitalised, or not hospitalised and are at high disease progression risk including hospitalisation or death.