- The US FDA gave the green light to Gilead’s antiviral drug Veklury® for hospitalized COVID-19 patients on 22 October.
- With FDA nod, Veklury® becomes the first approved treatment for COVID-19 in the US.
- The clinical studies showed that Veklury® significantly improved time to recovery by five days as compared to placebo.
On 22 October 2020, the US FDA gave the green light to Gilead’s Veklury® (remdesivir) making the antiviral drug the first officially approved treatment for COVID-19, an infection caused by the novel coronavirus, SARS-CoV-2.
The share price of Gilead Sciences Inc (NASDAQ:GILD) increased moderately by 0.76% to US$60.67 on 22 October 2020, after the announcement regarding the drug’s approval.
Let us dive deep and discuss in detail-
About Gilead Sciences
California-headquartered research-based biopharmaceutical company, Gilead Sciences Inc, is engaged in the development as well as commercialization of innovative medicines for diseases with unmet medical needs. Gilead has its operations in over thirty-five countries across the world.
Veklury®- the First FDA-Approved Treatment for COVID-19
On 22 October 2020, Gilead Sciences announced that the US Food and Drug Administration (FDA) had approved the antiviral drug Veklury® for the treatment of COVID-19 patients who require hospitalization.
Previously, the FDA had granted an Emergency Use Authorization (EUA) to Veklury® (remdesivir). With the go ahead, Veklury® becomes the first approved treatment for hospitalized COVID-19 patients in the US.
The drug is now widely available in hospitals across the US, after early investments to promptly expand manufacturing capacity of the Company for increasing supply.
Gilead said that the approval is based on three randomized controlled clinical trials. These include the final results of the NIAID’s double-blind, placebo-controlled Phase 3 ACTT-1 trial.
Phase 3 ACTT-1 trial demonstrated that Veklury® treatment resulted in clinically meaningful improvements across several result assessments as compared with placebo in COVID-19 hospitalized patients. The results showed that Veklury® significantly improved the time to recovery as compared to placebo.
Based on the potential of data, Veklury® has become a standard of care (SoC) for the treatment of hospitalized COVID-19 patients.
Besides approving Veklury®, the FDA also issued a new EUA for Veklury® for the treatment of hospitalized pediatric patients under the age of 12 years (weighing at least 3.5 kg). However, the Company said that this authorization is temporary and may be revoked. The FDA has not authorized the use of Veklury® in pediatric patients under 12 years (or having less than 40 kg body weight).
How does Veklury® work?
Veklury® is an antiviral drug that works by ceasing the replication of coronavirus. In the US, Veklury® is indicated for adults as well as pediatric patients (≥12 years and weighing at least 40 kg) for the COVID-19 treatment that requires hospitalization.
Gilead disclosed that Veklury® should only be given in a healthcare setting or a hospital capable of offering acute care as compared to inpatient hospital care.