Veklury

Veklury is given via infusion (drip) into a vein. Treatment should start with a 200 mg infusion on the first day, followed by 100 mg once a day. The total duration of treatment should be at least 5 days and no more than 10 days.

The medicine can only be obtained with a prescription and its use is limited to healthcare facilities in which patients can be monitored closely.

For more information about using Veklury, see the package leaflet or contact your doctor or pharmacist.

The active substance in Veklury, remdesivir, is a viral RNA polymerase inhibitor. It interferes with the production of viral RNA (genetic material), preventing the virus from multiplying inside cells. This can help the body to overcome the virus infection, and may help patients get better faster.

A main study (NIAID-ACTT-1) involving 1,063 hospitalised patients with COVID-19 (120 with mild to moderate disease and 943 with severe disease) showed that Veklury can speed up the recovery time in some patients, allowing them to spend less time in hospital or on treatment.

The study showed that, in the overall study population, patients treated with Veklury recovered after about 11 days, compared with 15 days for patients given placebo (a dummy treatment). For patients with severe disease requiring supplemental oxygen, time to recovery was 12 days for patients given remdesivir, compared with 18 days for patients on placebo. However, no difference was seen in time to recovery in the subgroup of patients with severe disease who started remdesivir when they were already on mechanical ventilation or ECMO (extracorporeal membrane oxygenation). No difference was also observed in patients with mild/moderate disease not requiring supplemental oxygen: time to recovery was 5 days for both the remdesivir group and the placebo group.

The study also showed that, in the overall study population, the mortality rate (the proportion of patients who died) 28 days after treatment started was 11.6% for patients given Veklury and 15.4% for patients on placebo. However, this effect was mainly driven by patients requiring supplemental oxygen in the form of low- flow oxygen at the start of treatment. No beneficial effect of Veklury on mortality was seen in the subgroup of patients with severe disease who started remdesivir when they were already on mechanical ventilation or ECMO.

The most common side effect with Veklury (which may affect more than 1 in 10 people) in healthy volunteers is raised blood levels of liver enzymes (a sign of liver problems). The most common side effects in patients with COVID-19 is nausea (feeling sick), which may affect up to 1 in 10 people.

For the full list of side effects and restrictions of Veklury, see the package leaflet.

Veklury showed a clinically meaningful effect on time to recovery in COVID-19 patients with pneumonia requiring supplemental oxygen, while being well tolerated with mild side effects. The European Medicines Agency therefore decided that Veklury’s benefits are greater than its risks and that it can be authorised for use in the EU.

In the context of the public health emergency and the urgent need for effective treatments for COVID-19, Veklury has been given a ‘conditional marketing authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. The Agency will review any new information that becomes available and this overview will be updated as necessary.

Since Veklury has been given conditional authorisation, the company that markets the medicine will provide to the Agency further data on the quality of the medicine by June 2021, and the final reports of studies with Veklury by December 2020.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Veklury have been included in the summary of product characteristics and the package leaflet.

A risk management plan for Veklury is also in place, which details important information about the medicine’s safety, how to collect further information and how to minimise any potential risks. 

As for all medicines, data on the use of Veklury are continuously monitored. Side effects reported with Veklury are carefully evaluated and any necessary action taken to protect patients.

Veklury received a conditional marketing authorisation valid throughout the EU on 3 July 2020.