Home Health Covid: the pill that halves deaths and hospitalizations is ready to land in Europe

Covid: the pill that halves deaths and hospitalizations is ready to land in Europe

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It could be the first pill capable of halving the risk of hospitalization and death for those with Covid in a mild or moderate way. An antiviral that can also be taken at home if necessary to avoid ending up in hospital. It is the antiviral molnupiravir developed by Msd (Merck & co) and Ridgeback Biotherapeutics now on the table of the EMA, the European drug agency, which will begin its evaluation in these days which could end in a couple of months. From 2022, therefore, in addition to vaccines, we will also be able to have a first therapy that is easy to use for the early stages of the disease. In the pipeline, 10 million capsules are already planned by 2021 and 20 million the year after.

After the FDA now the evaluation of the EMA starts

After having filed an emergency authorization request with the American Food and Drug Administration (Fda) now the dossier of the molnupiravir pill is on the table of the European Agency which should begin its “rolling review” these days. The announcement is now imminent and could arrive at the EMA press briefing on 21 October. If licensed, it could be the first oral antiviral drug to treat disease caused by the Sars-CoV-2 coronavirus. Usually the EU Agency takes about 2-3 months for the authorization, while the American FDA will meet on November 30 to discuss whether or not to authorize the experimental antiviral against Covid.

After the vaccines, the first antiviral is coming

Application submission in the United States is based on the positive results of a planned interim review of the Phase 3 Move-Out clinical trial. Analysis that molnupiravir reduced the risk of hospitalization or death by approximately 50%. Gianni Rezza, Director of Prevention of the Ministry of Health spoke in recent days of «promising results to be evaluated carefully. We already have vaccines and monoclonal antibodies available, but there is still a lack of antivirals. It is not easy to develop an antiviral for a virus that, unlike others, replicates quickly and from an extremely acute disease “, but having it” would allow us to have a portfolio of tools that make us able to fight “a virus that” it is becoming endemic ».

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Production has already started for 2021 and 2022

To guarantee access to treatment even before waiting for the authorizations of the regulatory bodies, MSD has started the production of molnupiravir: 10 million capsules will be available on the market by the end of 2021 and double the number of doses – 20 million – will be produced in the 2022. The company has entered into a procurement agreement with the US government (for approximately 1.7 million doses after regulatory green light) and is entering into purchase and supply agreements with other governments worldwide, always subject to the green light to drug. England, for example, has just booked 480,000. As regards prices, the aim is to adopt a differentiated pricing policy, capable of reflecting the different ability of individual states to finance the healthcare response to the pandemic. Another move is voluntary non-exclusive licensing agreements with generic drug manufacturers to accelerate the availability of molnupiravir in more than 100 low- or middle-income countries.

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