Updated: Nov 5, 2021
Merck’s molnupiravir has been approved in the UK to treat Covid-19 and here is all we know so far.
Formulation : It is a monoclonal antibody.
Monoclonal antibodies are man-made proteins that are created to target specific substances (in the body). Some are used to block receptors found on cells and their components, others are used to deliver other substances, some are used to modify the behaviour of the bound substance.
How it works
The monoclonal antibodies are claimed to introduce a fault in the genetic code of the Covid-19 virus. The corruption of Covid-19 genetic material that would result will prevent the virus from replicating itself, preventing it from invading more cells. Viruses have been historically difficult to kill. A success here would be the dawn to a new scientific triumph. Time will tell.
The UK’s medicines regulatory agency known as the MHRA approved the molnupiravir treatment today following ‘a stringent review’ that found it to be ‘safe and effective’. The drug receives special treatment under what The MHRA calls Great Britain Conditional Marketing Authorisation. This is a type of authorisation that is given to fast track important medicines that fulfil an unmet medical need. The UK agency was the first to approve the general use of a Covid-19 vaccine in the world when it approved the Pfizer-BioNTech vaccine in December 2020. The MHRA is demonstrating an exceptional reputation as the global leader following these two important firsts at a time they have been needed most.
The Washington Post reports that the US government pre-purchased 1.7 million doses at $700 each. From this, we can safely estimate that prior to all the volume and pre-ordering discounts, plus all other commercial maneuvers being applied, the treatment course will be $1000+, at least to start. It is claimed that this treatment is more accessible especially to countries with poor infrastructure due to the logistical convenience that pills provide. Merck has also agreed to share its license with other manufacturers in a bid to increase access for populations in countries with less economic security.
Lagevrio is what the molnupiravir treatment will be called in The UK.
Who can you prescribe it to
Molnupiravir has been authorised for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease. Source
When will it be available
Merck will be releasing 10 million courses in 2021 and 20 million in 2022. We anticipate that it will not be easy to access. When claims were made that Roactemra (Tocilizumab) was useful in Covid-19 treatment, Roche (UK) restricted access by supplying individual vials directly to hospitals only. Roche told Clynxx in July 2021 that they were “not in a position currently to open up new routes to patient[s] for this product” Merck claims to be committed to accessibility. Our specialist supplier pharmacy partners have informed Clynxx that it will be possible to access this treatment for private treatments in the UK only on a case by case basis before the end of 2022. Based on the licensing, it is unlikely that there will be a Hospital only restriction.
Prescribers can sign up to Clynxx to be the first to prescribe Lagevrio when it becomes available.