Sajid Javid (UK Chancellor of the Exchequer) has announced scarcely two hours ago that the UK has become the first country in the world to approve the use of a pill against the COVID-19.
The MHRA approved it as safe and effective treatment “after a rigorous assessment process”, underscored Javid.
It is called Molnupiravir and has been invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Then the drug has been developped by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics.
” In the clinical trials this treatment has been shown to reduce the risk of hospitalization or death for COVID-19 patients, who are most at risk by 50%”, pointed Sajid Javid.
“Along with the vital protection provided by our vaccines, this treatment can prevent those who are most at risk from becoming seriously ill with Covid” added Boris Johnson.
As this is an oral treatment baked into a bare pill, Molnupiravir is specially indicated for low and middle income countries and population segments, as the administration is as simple as taking the pill in one’s own home and complying with complex and/or expensive indications for storage is not needed.
Molnupiravir has become the first approved for use oral antiviral medicine for COVID-19 in the world.
Merk has announced that they have applied for autorisation by UN WHO, the US FDA and European Union EMA. Molnupiravir is currently under permanent revision by EMA.
¿What is the Molnupiravir?
Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.
This medicament could be also used, should tests prove it is effective, for post-exposure prophylaxis preventing the spread of COVID-19 within households.
On 1st October 2021 Merk announced that the Interim analysis in 3rd phase of trials, 7.3% t of patients, who received Molnupiravir were Hospitalized through day 29, compared with 14.1% placebo-treated patients who were hospitalized or died.
Merk plans to provide widespread acces to Molnupiravir at prices set for each country’s purse
In anticipation of the results from MOVe-OUT, Merck has been producing molnupiravir at risk. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the U.S. FDA. Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.
Merck is committed to providing timely access to Molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.
As part of its commitment to widespread global access, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.