Gilead's remdesivir becomes first treatment approved in Europe for severe Covid-19

LONDON, 3 July (APM) - Gilead announced on Friday that the European Commission has conditionally approved remdesivir under the brand name Veklury for adults and adolescents who are seriously ill with severe Covid-19.
Veklury is indicated to treat severe Covid-19 in patients aged 12 years and older weighing at least 40 kg, Gilead said in a statement.
Gilead said Veklury is the first approved treatment for Covid-19 in Europe. The drug, which was recommended for conditional approval in this setting by the European Medicines Agency in June, is approved to treat patients who have pneumonia and require supplemental oxygen (APMHE 67900).
Priced at $2,340 for a five-day treatment in the U.S. and some other developed countries, Veklury's approval was based on the "interest of public health due to the Covid-19 pandemic", according to Gilead (APMHE 67943).
Merdad Parsey, chief medical officer at Gilead said: "We appreciate the European Medicines Agency's rapid review of remdesivir in recognition of the unprecedented nature of this pandemic. This conditional marketing authorisation is an important step forward as we work together to address the treatment needs of patients across Europe."
Veklury's approval is supported by data from the U.S. National Institute of Allergy and Infectious Diseases' global Phase III trial of remdesivir, which was compared with placebo in the study.
Known as the NIAID-ACTT-1, the trial showed that patients treated with remdesivir recovered after about 11 days compared to 15 days with those on placebo (APMHE 67152).
This effect was only observed in the more serious cases, for those with mild to moderate disease the recovery rate was five days for treatment or placebo.
The conditional marketing authorisation in Europe means that ongoing licensure may hinge on further evidence generation.
Gilead confirmed that ongoing clinical trials continue to evaluate the safety and efficacy of the drug, including studies of Veklury in combination with anti-inflammatory medicines and in special populations, including paediatric patients.
Research is also being conducted on new, investigational formulations of Veklury that may enable studies of the drug in earlier stages of disease.
Remdesivir only has emergency use authorisation the U.S. It was widely reported on Wednesday that the country secured more than 500,000 treatment courses of the drug (APMHE 67892).
However, Gilead said in June that it aims to supply sufficient volumes of remdesivir by the end of the year to treat more than two million Covid-19 patients (APMHE 67863).
Japan is the only other region at this time to have issued an official authorisation for the drug (APMHE 67266).



Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to the latest stories

Our coverage includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.


an initial 10 day temporary access of APM Health Europe.