Just as the MHRA was the first regulatory agency in the world to approve a COVID vaccine when it approved the Pfizer/BioNTech COVID-19 vaccine in December 2020, the MHRA has now achieved the feat again in approving an anti-COVID-19 pill.
The pill, molnupiravir (also known as Lagevrio), has been developed by Merck Sharp & Dohme and Ridgeback Biotherapeutics. It works by targeting an enzyme used by the coronavirus to make copies of itself, thereby preventing it from multiplying.
While other antiviral medications for COVID-19 must be injected or given intravenously, molnupiravir is a game changer because it can more simply be taken orally, which means it can be taken by people at home before symptoms become so severe that patients are hospitalised. It has also had an incredible effect in trials by reducing hospitalisations by 50%, and none of the patients who were given molnupiravir shortly after catching COVID-19 have died.
It has been approved for people with mild to moderate COVID-19 symptoms, who should take a course of the medication within five days of developing symptoms, and the UK has already ordered 480,000 doses. However, it is important to stress that the availability of an at-home treatment in no way diminishes the importance of getting vaccinated.
The UK being the first country to approve an anti-COVID pill cements its status as a world leader at the forefront of scientific and medical innovation. As we reported in July, the MHRA's new three-year delivery plan focuses on innovation, collaboration, and contributing towards scientific development. The MHRA is continuing to demonstrate that it can work quickly and thoroughly to facilitate and approve clinical trials which have generated a sound evidence base, in order to enable rapid but safe approval of licences for products.
Pfizer and Roche are also working on COVID-19 anti-viral treatment pills.
The 2021 PING Conference, which VWV will be holding in collaboration with IQVIA, is entitled 'UK Life Sciences Opportunities in a Changed World'. The Conference will look at many ways in which the UK is now innovating and bringing new treatments to patients. This will include hearing from Dr Kirsty Wydenbach, Expert Medical Assessor and the Deputy Unit Manager in the Clinical Trials Unit at MHRA, who will be speaking about 'MHRA innovation supporting the UK to be a global life sciences super-power'.
Amongst others, we will also be hearing at the Conference from the following speakers:
Find out more about the PING Conference 2021.