EMA recommends expanding access to remdesivir

EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID‑19 can be treated.

In addition to patients undergoing invasive mechanical ventilation, the compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation).

The updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19. EMA is currently evaluating these data in the context of the rolling review of remdesivir.

In addition, a treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from another study (GS-US-540-5773) suggesting that for patients not requiring mechanical ventilation or ECMO, the treatment course may be shortened from 10 to 5 days without any loss of efficacy. Patients who receive a 5-day treatment course but do not show clinical improvement will be eligible to continue receiving remdesivir for an additional 5 days. The option to shorten treatment duration also means that more patients may be able to receive the medicine, which is in very high demand worldwide.

Although remdesivir is not yet authorised for marketing in the European Union, these recommendations for compassionate use will help some patients with severe COVID-19 access the medicine while EMA evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a marketing authorisation.

On 30 April 2020, the EMA also announced the start of a rolling review for data related to evaluating remdesivir in the EU, [2]

comment

The UK MHRA have already approved access to remdesivir, although criteria exclude important people who could benefit.

Remdesivir should be considered the new standard of care in appropriate research studies.