untitled design

The anti-Covid pill is coming: green light in the United Kingdom for the Merck drug

Green light in the UK al molnupiravir, the anti-Covid pill developed by the pharmaceutical giant Merck (outside the United States and Canada known as MSD, Merck, Sharp & Dohme), together with Ridgeback Biotherapeutics. The results of phase 3 clinical tests on 775 people explain that the drug, taken at the indicated times and doses (two pills a day for a total of 800 mg for five days in the early stages of infection) ensures the halving hospitalizations and deaths in people not vaccinated and at risk of developing complications. Among other things, 80% of the cases concerned related to virus variants such as Delta, Gamma and Mu. Britain is the first country in the world to approve this antiviral, in fact the first, true and for now the only drug available to us against Covid-19, rather against severe forms in certain specific conditions, those of people with at least one risk factor.

The MHRA, that is the British Medicines Agency, has therefore authorized the drug that will be marketed under the name of Lagevrio. It is a viral RNA polymerase inhibitor which interferes with the production of the genetic material (Rna) of viruses: in short, it sabotages its genetic replication. By interfering with the RNA production of Sars-CoV-2, molnupiravir prevents – in half of the cases – the proliferation of the virus. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has instead initiated the rolling review, i.e. the continuing review of the antiviral (also known as MK 4482) just a few days ago, on October 25th. It will therefore take some time to be able to use it also in the 27 European countries.

Signage outside Merck & Co. headquarters in Kenilworth, New Jersey, U.S., on Monday, Jan. 25, 2021. Merck & Co. is discontinuing development of its two experimental Covid-19 vaccines after early trial data showed they failed to generate immune responses comparable to a natural infection or existing vaccines. Photographer: Christopher Occhicone/Bloomberg via Getty ImagesBloomberg

But there is an alternative way to have the anti-Covid pill available ahead of time. He suggested it yesterday Marco Cavaleri, vaccines manager of the EMA: “Studies suggest that the oral antiviral molnupiravir (Merck) can reduce the ability of the coronavirus to multiply in the body, thus preventing hospitalization or death in infected patients” confirmed. For this reason, the Agency said “it is ready to advise Member States so that they can make this new treatment available for emergency use, prior to a marketing authorization“. In short, just like the booster dose for Johnson & Johnson, Aifa could also be on the drug intervene before the EMA. For its part, the Agency will provide an update when the application for marketing authorization for the medicinal product is submitted: for now Merck has also submitted it to the WHO but the intention is to forward it to all other regulatory bodies.

On the other hand, the FDA also continues to examine the non-clinical and clinical data of the drug. According to Merck, production could stand at 10 million cycles by the end of the year e at least double in 2022. They are not huge numbers but considering that they would intervene in a specific phase and range they could make a difference. “Today is a historic day for our country as the UK becomes the first country in the world to have approved an antiviral against Covid-19 that can be taken at home,” he said. Sajid Javid, Johnson Government Minister of Health. The drug will initially be available to 480,000 people.

item picture

Call back Johnson & Johnson, green light from Aifa: 1.5 million Italians involved

The Agency’s CTS anticipates the EMA and gives the booster a green light at least six months after administration

Read the article

Each cycle will cost 700 dollars. However, the company has granted a royalty-free license to Medicines Patent Pool, a non-profit organization that works with the UN. This agreement will allow manufacturing centers in 105 poor countries, especially in Asia and Africa, to produce and sell a version of molnupiravir. low price.

Additionally Merck, Ridgeback Botherapeutics and the Emory University di Atlanta (who discovered the molecule he was working on, for other purposes, since 2013) they will not receive royalties for sales of the drug until Covid-19 is classified by WHO as a public health emergency of international concern. In the higher-income and wealthier countries, however, the pills would be sold at higher prices. While many countries have already ordered tens of thousands if not millions of cycles (France had ordered 50,000 doses and the United States 1.7 million at the end of October), it does not appear that the EU as a whole has moved in this direction.

Other stories of Vanity Fair that may interest you

New Novavax vaccine: how the anti-Covid serum authorized in Indonesia works

Covid vaccine for children, the FDA committee gives the green light between 5 and 11 years

.

You may also like

Get the latest

Stay Informed: Get the Latest Updates and Insights

 

Most popular