CHMP begins rolling review of COVID oral antiviral
pharmafile | October 26, 2021 | News story | Manufacturing and Production |
The EMA’s human medicine’s committee (CHMP) has initiated a rolling review of the investigational antiviral drug molnupiravir for the treatment of COVID-19, from the US pharmaceutical firm Merck. This treatment raises hopes for an easily administered treatment to reduce serious or deadly cases of COVID.
This move could eventually lead to the authorisation of the antiviral on the European market. Antivirals such as molnupiravir operate by decreasing the ability of a virus to replicate, which reduces spread of the disease.
Merck has also applied for emergency use of the anti-coronavirus drug in the US. Molnupiravir appears to reduce the “ability of SARS-CoV-2 to multiply in the body, thereby preventing hospitalisation or death in patients with COVID-19,” according to the EMA.
Given to patients within days of a positive test, the treatment halves the risk of hospitalisation and death, according to a clinical trial conducted by Merck.
The EMA will evaluate more data on the quality, safety, and effectiveness of the medicine. The rolling review will continue until enough evidence is available for the company to submit a formal marketing authorisation application. If approved, molnupiravir would represent a major breakthrough in reducing severe forms of the disease, which Merck’s FDA application stated reduced hospitalisations by 50%.
However, it can take several months between the beginning of a rolling review by the EMA and an eventual green light, if it is given.
If granted marketing authorisation by the European Commission, molnupiravir could be the first oral antiviral medicine for the treatment of COVID-19 in the EU.
Ana Ovey
