European Commission secures EU access to Remdesivir for treatment of COVID-19

Yesterday, the European Commission has signed a contract with the pharmaceutical company Gilead to secure treatment doses of Veklury, the brand name for Remdesivir. Veklury was the first medicine authorised at EU level for treatment of COVID-19. As from early August onwards, and in order to meet immediate needs, batches of Veklury will be made available to Member States and the UK, with the coordination and support of the Commission.

Stella Kyriakides, Commissioner for Health and Food Safety, said: “In recent weeks, the Commission has been working tirelessly with Gilead to reach an agreement to ensure that stocks of the first treatment authorised against COVID-19 are delivered to the EU. A contract has been signed yesterday, less than a month after the authorisation of Remdesivir, which will allow the delivery of treatments from early August for thousands of patients. The Commission is leaving no stone unturned in its efforts to secure access to safe and efficient treatments, and is supporting the development of vaccines against coronavirus. Yesterday’s agreement is another important step forward in our fight to overcome this disease”.

The Commission’s Emergency Support Instrument will finance the contract, worth a total of €63 million. This will ensure the treatment of approximately 30,000 patients presenting severe COVID-19 symptoms. This will help to cover the current needs over the next few months, while ensuring a fair distribution at EU level, based on an allocation key, taking into account the advice from the European Centre for Disease Prevention and Control.

The Commission is now also preparing a joint procurement for further supplies of the medicine, expected to cover additional needs and supplies as from October onwards.

Background

On 3 July, Remdesivir became the first treatment to be authorised for a conditional marketing authorisation. This authorisation facilitates early access to medicines in public health emergency situations, such as the current pandemic.

Remdesivir is a treatment against COVID-19 for adults and adolescents as from age 12 with pneumonia who require supplemental oxygen. The application for the marketing authorisation was submitted to the European Medicines Agency (EMA) on 8 June. EMA’s recommendation was endorsed by the Member States through the Standing Committee on Medicinal Products for Human Use.

While authorised in the EU, the medicine continues to be monitored to ensure safety. Gilead has also been requested to submit the final reports of the Remdesivir studies to the EMA by December 2020 as part of the conditions to be fulfilled to move from a conditional marketing authorisation to a full marketing authorisation. Further data on the effectiveness and safety of the medicine is expected to be submitted by August 2020 in order to finalise this process.

More Information

EU legislation on medicinal products

EMA and COVID-19 treatments

Source


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