LAGEVRIO. The government is authorizing the prescription of Molnupiravir, marketed under the name Lagevrio, which has received the green light from the European Medicines Agency. This medicine will be reserved for people who are at risk of developing severe forms, who are over 65 years of age and are symptomatic or because they have chronic diseases. Manual.
[Mise à jour le 25 novembre 2021 à 13h55] The government authorizes the prescription of Molnupiravir in pharmacies, marketed under the name Lagevrio, announced the Minister of Health Olivier Véran on November 25 during a press conference. This is a antiviral drug administered orally initially intended for the treatment of influenza and hepatitis C. Developed by the American laboratory Merck and Ridgeback Biotherapeutics, this is the first drug in tablets to be taken at the first symptoms of Covid to avoid a worsening of the disease. “This medicine will be reserved for people who are at risk of developing severe forms, who are over 65 years of age and are symptomatic or because they have chronic diseases”, detailed the minister. Your doctors will receive the indications and the rules for prescribing this medicine. This drug, if given within the first five days can halve the risk of being hospitalized. France will be the first European country to benefit its citizens ”
After being cleared in the UK by the MHRA (British health agency) in early November, he just received the green light from the European Medicines Agency (EMA) November 19 for “to be used for treat adults with Covid-19 who do not need supplemental oxygen and who are at increased risk of developing severe Covid-19. Lagevrio should be administered as soon as possible after the diagnosis of Covid-19 and within 5 days of the onset of symptoms. The drug, which is available in capsule form, should be taken twice a day for 5 days. ” The EMA issued this opinion “to support national authorities who may decide on a possible early use of the medicine before marketing authorization, for example in emergency situations, in light of the increasing rates of infection and death from COVID-19 in the EU ” she explains. The drug Lagevrio, when given at a dose of 800 mg twice a day, reduced the risk of hospitalization and death when treatment was started within 5 days of the onset of symptoms. About one month after starting treatment 7.3% of patients (28 of 385) who took Lagevrio versus 14.1% (53 of 377) of those who took placebo had been hospitalized or died; none of the patients in the Lagevrio group died compared to eight patients in the placebo group. In terms of security, most frequently reported side effects during treatment and within 14 days of the last dose of Lagevrio were diarrhea, nausea, dizziness and headache, all mild or moderate. What is the Molnupiravir ? What is its composition? Its effect against Covid? For who ? Discovery.
What is Molnupiravir?
Molnupiravir also called “MK-4482” or “Lagevrio” is a antiviral drug administered orally originally intended for the treatment of influenza and hepatitis C. It has been invented at Emory University by Drug Innovation Ventures at Emory (DRIVE), LLC, the university-owned start-up to advance the development of early candidate treatments for world-class viral diseases, and licensed by Ridgeback Biotherapeutics.
What is the composition of Molnupiravir?
The characteristics of the treatment were published by the UK government on November 4 and confirmed by theEMA. The drug is called Lagevrio and contains 200mg of molnupiravir per capsule. These capsules will be 21.7mm * 7.6mm orange in size with the MSD logo printed on it and the number 82. List of excipients contained in the capsule:
- Croscarmellose sodium (E468)
- Hydroxypropylcellulose (E463)
- Magnesium stearate (E470b)
- Microcrystalline cellulose (E460)
List of excipients contained in the “shell” of the capsule:
- Hypromellose (E464)
- Titanium dioxide (E171)
- Red iron oxide (E172)
List of excipients in the ink used for printing on the capsules:
- Butyl alcohol
- Dehydrated alcohol
- Isopropylic alcohol
- Potassium hydroxide
- Propylene glycol (E1520)
- Purified water
- Strong ammonia solution
- Titanium dioxide (E171)
Molnupiravir acts as a potent analogue du ribonucléoside who inhibits SARS-CoV-2 replication, the causative agent of Covid-19, incorporating into the coronavirus genome. It then leads to RNA replication errors of the virus preventing it from spreading. Concretely, after taking “the virus multiplies less or even more at all” Prof. Bruno Lina, virologist, explained on BFM-TV on October 27.
What effects against Covid?
The purpose of Molnupiravir is to reduce the risk of developing a severe form of Covid and the duration of the illness. At a phase 3 clinical trial carried out on more than 1,500 patients and relayed by the Merck laboratory, taking 800 mg of Molnupiravir, twice a day, has reduces the risk of hospitalization or death of Covid patients by approximately 50%. About one month after starting treatment 7.3% of patients (28 of 385) who took Lagevrio versus 14.1% (53 of 377) of those who took placebo had been hospitalized or died; none of the patients in the Lagevrio group died compared to eight patients in the placebo group. “In addition, preclinical and clinical data have shown that Molnupiravir was active against variants most common types of SARS-CoV-2 (including Delta, editor’s note) “ explained the laboratory Merck.
It does not replace vaccination but is complementary.
What side effects?
According to the US trial reported by Merck, the incidence of any adverse event was comparable in the groups of patients who received Molnupiravir and those in the placebo group (35% and 40%, respectively). Fewer subjects in the Molnupiravir group discontinued treatment due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively). Among the most common adverse reactions (≥ 1% of subjects) reported during treatment and for 14 days after the last dose were there diarrhea (3%), nausea (2%), dizziness (1%) and headache (1%), all grade 1 (mild) or grade 2 (moderate).
For who ?
Molnupiravir is for adults “with Covid-19 who do not need supplemental oxygen and who are at increased risk of developing severe Covid-19. Lagevrio should be administered as soon as possible after the diagnosis of Covid-19 and within 5 days of onset of symptoms “ EMA clarified on November 19.
Can it be used in pregnant women?
No. In accordance with the recommendations of the EMA, “Lagevrio is not recommended during pregnancy and in women who may become pregnant.t not using effective contraception. Women who may become pregnant should use effective contraception during treatment and for 4 days after the last dose of Lagevrio. Breast-feeding should be discontinued during treatment and for 4 days after treatment. These recommendations are given because laboratory studies in animals have shown that high doses of Lagevrio may have an impact on the growth and development of the fetus “.
When to take it
The drug should be taken within 5 days of the onset of symptoms, the EMA explained, according to its manufacturer’s recommendations. “It is effective at the virological stage of the disease, ie the first phase of the disease when the virus is responsible for the symptoms but before the disease has set in” explained Professor Lina on BFM-TV on October 27. It does not replace vaccination but is complementary: “We are in the reaction with the treatment of Molnupiravir while we are in prevention with the vaccine. “
What is its dosage?
L’EMA specified the following dosage for the drug Lagevrio: 800 mg (4 capsules of 200 mg) orally every 12 hours for 5 days.
What is the price ?
The price of the drug in France has not yet been released. The United States has ordered 3.1 million doses for nearly $ 2.2 billion, or about 710 dollars for each (610 euros).
Merck and Ridgeback Announce Initiation of a Rolling Review by the European Medicines Agency for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of COVID-19 in Adults. Merck. 25 octobre 2021.
COVID-19: EMA starts rolling review of molnupiravir. EMA. 25 octobre. 2021.