As of this morning – Friday June 26 – the current recorded case count for COVID-19 (coronavirus) in the UK has reached 307,980 with 43,230 deaths.
The EMA’s human medicines committee (CHMP) is backing approval of Gilead's remdesivir – under the brand name Veklury – for the treatment of COVID-19 in patients aged 12 years and over with pneumonia who require supplemental oxygen.
The move sees remdesivir become the first medicine against COVID-19 to be recommended for authorisation in the EU.
Data on the drug were assessed in “an exceptionally short timeframe” through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available.
From 30 April 2020, the CHMP began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programmes, well in advance of the submission of the marketing authorisation application on 5 June.
The decision to back the drug's approval in this setting is mainly based on data from the US National Institute of Allergy and Infectious Diseases (NIAID) study NIAID-ACTT-11, which found that patients treated with remdesivir recovered after about 11 days, compared with 15 days for patients given placebo.
However, the agency stressed that this effect was not seen in patients with mild to moderate disease: time to recovery was five days for both the remdesivir group and the placebo group. For patients with severe disease, who constituted approximately 90% of the study population, time to recovery was 12 days in the remdesivir group and 18 days in the placebo group.
Taking into consideration the available data, the CHMP felt the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease.
As the recommended authorisation is a conditional one, Gilead would have to submit final reports of the remdesivir studies by December 2020, and further data on the quality of the medicine, as well as the final data on mortality, by August 2020, in order to better characterise the drug's effectiveness and safety.
The European Commission will now fast-track the decision-making process with the aim of granting a decision on the conditional marketing authorisation for remdesivir in the coming week, allowing the product to be marketed in the EU.