The first oral antiviral for the treatment of COVID-19 has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), in a move that the health secretary said was a “historic day for our country”.
The UK medicines regulator announced on 4 November 2021 that it had authorised molnupiravir for use in people who have mild-to-moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age (>60 years), diabetes mellitus or heart disease.
The investigational antiviral, which was developed by Merck Sharp & Dohme (MSD) in partnership with Ridgeback Biotherapeutics, works by interfering with the virus’ replication, preventing it from multiplying and reducing the severity of the disease.
Clinical trial results suggest that the drug was most effective when taken during the early stages of infection, leading the MHRA to recommend its use as soon as possible following a positive COVID-19 test and within five days of symptom onset.
Sajid Javid, UK health and social secretary, said: “Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID-19.
“This will be a game-changer for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment.”
Javid added that the government were “working at pace” with the NHS to set out plans to deploy molnupiravir to patients through a national study “as soon as possible”.
At a press conference at Downing Street on 20 October 2021, Javid announced that 480,000 doses of the antiviral had been ordered by government, along with 250,000 doses of another antiviral, PF-07321332/ritonavir, which has been developed by Pfizer.
June Raine, chief executive of the MHRA, said that molnupiravir was another therapeutic to add to the “armoury” against COVID-19.
“It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage,” she said.
“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”
As yet unpublished results from a planned interim analysis of a global, phase III, randomised controlled trial, released by MSD on 1 October 2021, suggested that molnupiravir could reduce the risk of hospitalisation or death from COVID-19 by around 50%. In the trial, 7.3% of patients who received molnupiravir were either hospitalised or had died by day 29 compared with 14.1% of placebo-treated patients.
A trial to evaluate antiviral treatment in people in the community who are at a higher risk of complications from COVID-19 was announced on 27 October 2021. Researchers said the PANORAMIC trial will begin recruitment shortly and that they hoped pharmacies would play an important part in that effort.