October 1, 2021 – 17:07
Molnupiravir introduces copy errors during the replication of the virus’ RNA, thus preventing duplication
Merck (Msd) and Ridgeback Biotherapeutics announced today that molnupiravir (MK- 4482, EIDD-2801), an oral antiviral undergoing clinical trial , “reduced the risk of hospitalization or death by approximately 50% based on the results of the phase III interim analysis of the Move- Out conducted on non-hospitalized adult patients at risk with Covid-19 in mild or moderate form “. Merck now wants to apply for authorization for emergency use in the United States “as soon as possible and, at the same time, request authorization from regulatory agencies around the world”.
Halved the risk of hospitalization and death
Molnupiravir in fact shows to be able to reduce by about 50% the risk of hospitalization and death in patients with mild or moderate Covid. As noted in the note, if approved, molnupiravir could be the first antiviral drug in use for the treatment of Covid-19. According to data from the interim analysis, 7.3% of patients who received molnupiravir were hospitalized or died within the 29th day from the time of randomization (28/385), compared with 14.1% of patients who were treated with placebo (53/377). Furthermore, up to the 29th day of administration, no deaths were reported in subjects who received the drug, compared with 8 deaths treated with placebo. The two companies explained, with these positive results in hand, that patient recruitment was stopped early, following the recommendations of an independent data monitoring committee and in consultation with the US FDA.
Robert M. Davis, Chief Executive Officer and President of MSD said: “The pandemic urgently requires new therapeutic options and treatments. Covid- 19 is now a leading cause of death and continues to have a significant impact on patients, their families, society at large as well as healthcare systems around the world. We are confident that molnupiravir can represent an important treatment option and a essential component of the global effort to combat the pandemic “.
Molnupiravir is effective against variants
The results of the Interim Analysis plan ta evaluated data from 775 patients initially involved in the phase III trial by 5 August 2021. Eligibility criteria required all patients to have a laboratory-confirmed mild or moderate diagnosis of Covid-19, with symptoms appearing within 5 days of randomization into the study. All patients were considered to be at high risk of serious illness due to health problems such as obesity, diabetes, or heart disease. Antiviral reduced the risk of hospitalization and / or death in all major study subgroups. It should be emphasized that the effectiveness of the drug was not influenced by the date of onset of symptoms or by other risk factors. Furthermore, based on the participants enrolled with viral sequencing data (approximately 40%), molnupiravir demonstrated significant efficacy in all known viral variants, Gamma, Delta and Mu. The incidence of each adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). Furthermore, the incidence of drug-related adverse events was comparable (12% and 11%, respectively). Fewer patients discontinued therapy in the molnupiravir control group (1.3%) than in the placebo group (3.4%).
10 million doses produced by 2021
“Antiviral therapies that can be taken at home without hospitalization of the patient represent today a fundamental therapeutic option. We are proud “ said Wendy Holman, Chief Executive Officer of Ridgeback Biotherapeutics. MSD has already started production of molnupiravir and intends to produce 10 million doses by the end of 2021. More will be produced later in 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 drug’s green light. The intention is to adopt a differentiated pricing policy, capable of reflecting the different ability of individual states to finance the healthcare response to the pandemic. Voluntary non-exclusive licensing agreements are also envisaged with manufacturers of generic drugs in order to accelerate the availability of the additional drug. from 100 low- and middle-income countries The pill works by interfering with an enzyme, pol viral imerase, which the coronavirus uses to copy its genetic code and reproduce. By exerting its antiviral action through the introduction of copying errors during the replication of the virus’ RNA, it effectively prevents its duplication.
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