On the 3rd of July we arrived to another milestone in the fight against the novel coronavirus infection. Eurpean Comission grants conditional marketing authorization for Gilead’s Veklury (remdesivir), thus it is the first approved treatment option for COVID-19 in the EU.
Previously we reported that Japan was one of the first countries who approved remdesivir for COVID-19. Several other countries followed the Japanese example and now, after the European Medicines Agency (EMA) reviewed remdesivir, Veklury has been granted the authorization for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen.
“We appreciate the European Medicines Agency’s rapid review of remdesivir in recognition of the unprecedented nature of this pandemic,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “This conditional marketing authorization is an important step forward as we work together to address the treatment needs of patients across Europe.”
A conditional marketing authorization means that it is is initially valid for one year in Europe, but can be extended or converted into an unconditional marketing authorization after the submission and assessment of additional confirmatory data.
The pricing policy in Europe is not yet revealed, but it is known that, for governments in developed countries remdesivir would be priced at $390 per vial, meaning a course of six vials would cost $2,340 per patient, and $520 per vial for private insurers.