News Analysis India

Tag: molnupiravir

  • COVID: Maharashtra government says Molnupiravir must be used with caution

    By PTI

    PUNE: The Maharashtra government on Monday issued a letter to the district, civic administrations and health departments in the state asking them to use oral anti-viral drug ‘Molnupiravir’ for treatment of symptomatic, adult COVID-19 patients with “abundant caution and in certain conditions”.

    Dr Pradeep Vyas, additional chief secretary (health), in the letter, requested district and civic authorities to use Molnupiravir with “abundant caution and in certain conditions and in full advised dose”.

    He said this drug has received emergency use authorization (from the Drug Controller General of India) and based on the opinion of some experts it has also been included in treatment protocol circulated on January 6, 2022, in the state subject to certain conditions.

    “Subsequently, certain state governments like Odisha have withdrawn this drug from the market. ICMR has also not recommended its use in the treatment of SARS-CoV-2 infection (which causes COVID-19). Molnupiravir has not been included in the Standard Treatment Protocol released by the Government of India on January 17, 2022,” Dr Vyas said in the letter.

    Molnupiravir has been shown to reduce hospitalization in a clinical trial and thus has received emergency use authorization, not an FDA approval, the letter stated.

    “Till further clarity is received, you are requested to please use Molnupiravir with abundant caution and in certain conditions and that also in full advised dose,” the senior bureaucrat stated.

    The letter-cum advisory said the drug may be “prescribed for the treatment of COVID-19 in patients who have mild illness not requiring oxygen, one or more risk factors that will cause hospitalization and impending severe disease, in whom there are no other options available, where there are no contra-indications to the use of Molnupiravir’ and in the first five days of the illness”.

    However, patients under the age of 18 and pregnant women should not be given this drug, it maintained.

    Besides district and civic heads and health departments, the letter has been marked to district civil surgeons and health officers.

  • Molnupiravir not to be included in COVID-19 clinical management protocol as of now

    By PTI

    NEW DELHI: The ICMR’s National Task Force for COVID-19 has decided against including antiviral drug Molnupiravir in the Clinical Management Protocol for COVID-19 as of now, official sources said on Tuesday.

    The experts of the task force cited safety concerns and argued that Molnupiravir was not of much benefit in Covid treatment to arrive at the decision in a meeting held on Monday.

    According to the Health Ministry, Molnupiravir is an antiviral drug that inhibits SARS-CoV-2 replication by viral mutagenesis.

    This anti-Covid pill got the Drug Regulator General of India’s approval on December 28 for restricted use in emergencies.

    Mutagenesis is a process by which the genetic information of an organism is changed by the production of mutation.

    “Members of the National Task Force for COVID-19 were not in favour of including the drug in the national treatment guidelines citing that it does not have much benefit in the treatment of coronavirus infection and that there were safety concerns,” an official source told PTI.

    Indian Council of Medical Research (ICMR) chief Dr Balram Bhargava had last week said that Molnupiravir has major safety concerns.

    He added that WHO and the UK have not included it for treatment.

    “We have to remember that this drug has major safety concerns,” he said, adding, it can cause defects in a developing fetus and can damage the muscles also.

    “Contraception will have to be done for three months for male and female if this drug is given because the child born could be problematic due to teratogenic influence,” Dr Bhargava had said.

    The UK Medicines and Healthcare products Regulatory Agency had on December 4 granted approval for Molnupiravir under special conditions for treatment of mild to moderate COVID-19 in adults who have at least one risk factor for developing severe illness.

    USFDA on December 23 granted Emergency Use Authorisation for the drug for treating mild-to-moderate COVID-19 in adults at high risk for progression to severe disease, including hospitalization or death, and for whom alternative treatment options are not accessible or clinically appropriate.

    According to conditions, the drug should be sold by retail only under the prescription of medical specialists and the recommended dose should be 800 mg twice daily for five days.

  • Government panel recommends EUA for vaccines Covovax, Corbevax and anti-Covid pill molnupiravir

    By PTI

    NEW DELHI: An expert panel of the country’s central drug authority has recommended granting emergency use authorisation to Serum Institute of India’s COVID-19 vaccine Covovax and Biological E’s vaccine Corbevax with certain conditions, official sources said on Monday.

    The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday also recommended granting permission to manufacture and market anti-Covid pill Molnupiravir for restricted emergency use for treatment of adult patients with SpO2 93 per cent and who have high risk of progression of the disease, including hospitalisation or death, subject to certain conditions.

    All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.

    The SEC on COVID-19 of the CDSCO, which reviewed the emergency use authorisation (EUA) applications of Serum Institute of India (SII) for the second time on Monday, after detailed deliberation has recommended granting EUA to Covovax.

    “The committee noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO,” an official source said.

    Prakash Kumar Singh, director, government and regulatory affairs at SII, had submitted an application to the DCGI in October for grant of market authorisation for Covovax for restricted use in emergency situations.

    The DCGI office had granted SII permission to manufacture and stock Covovax on May 17.

    Based on DCGI approval, till now, the Pune-based firm has manufactured and stockpiled the vaccine doses.

    In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

    The World Health Organisation (WHO) had on December 17 issued emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.

    As for Biological E’s Corbevax, in light of the recommendations of the SEC meeting held on December 10, the firm submitted proposal for grant of marketing authorisation to the vaccine for restricted emergency use in adults along with the updated interim safety and immunogenicity data of phase 2/3 clinical trial and updated interim safety and immunogenicity data of phase 3 active comparator trial.

    The committee noted that the firm has submitted six months safety follow up post second dose from phase-1 clinical trial, 90 days safety from the phase -2 part and 60 days safety data from phase 2/3 and phase 3 active comparator study.

    The firm has submitted interim immunogenicity data from phase-3 active comparator trial which showed superiority against the comparator with respect to viral neutralization antibody titres, the official source said.

    “After detailed deliberation, the committee recommended for grant of marketing authorisation permission of SARS-CoV-2 (Covid-19) Vaccine containing RBD antigen of SARS-CoV-2 for restricted use in emergency situation subject to various regulatory provisions,” the source said.

    The vaccine should be administered intramuscularly in two doses of 0.

    5 ml each with interval of 28 days (Day 0 and 28) and has to be stored between 2 degrees Celsius to 8 degrees celsius,the source added.

    The SEC on Monday also recommended granting permission to manufacture and market anti- Covid pill Molnupiravir for restricted emergency use for treatment of adult COVID-19 patients with SpO2 93 per cent and who have high risk of progression of the disease, subject to certain conditions.

    Dr Reddy’s Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and Sun pharma had presented their proposal for approval of Molnupiravir 200mg capsules for approval in emergency situation along with various supporting documents.

    including clinical data in the country, official sources said.

    As per conditions, the drug should be sold by retail only under prescription of medical specialists.

    According to the conditions, the drug is not authorised for use in patients less than 18 years and for initiation of treatment in patients requiring immediate hospitalisation due to COVID-19 at that stage.

    However, if it was initiated before hospitalisation due to COVID 19, it may be continued, sources said.

    It is not authorsied for use for longer than five consecutive days and for pre-exposure or post exposure prophylaxis for prevention of COVID-19 for pregnant women.

    The US Food and Drug Administration recently authorised Merck’s Molnupiravir for treatment of mild-to-moderate COVID-19 cases in adults who are at risk for severe disease.

    Before that in November Britain granted conditional authorisation to Merck’s coronavirus antiviral, the first pill shown to successfully treat Covid-19.

    The pill is intended to be taken twice a day for five days by people at home with mild to moderate Covid-19.

    In a clinical trial of high risk people during the ealry course of illness,t he Merck’s drug was shown to reduce hospitalisations and deaths by around 30 per cent.

  • New drug Molnupiravir raises hope for mild Covid-19 cases

    By Express News Service

    BENGALURU: The experimental Covid-19 drug Molnupiravir could be promising in treating mild to moderate corona patients, going by the announcement made on October 2 by the company, Merck and Ridgeback Biotherapeutic, after completing Phase 3 trials.

    Going by data available so far, doctors say this could be useful in treating Covid patients in early stages, as the company reported a 50% drop in hospitalisation and death.

    “While we have medicines for moderate to severe patients, we are still struggling for mild patients. This drug could be a gamechanger. It can be taken orally in the out-patient department,” said Dr Chinnadurai R, lead consultant, Department of Critical Care, Aster RV Hospital.

    The data was drawn from 775 patients and reported 7.3% of patients who received the drug were either hospitalised or had died by day 29, compared to 14.1% of placebo patients.

    “Molnupiravir induces ‘lethal mutagenesis’, thereby reducing viral replication; Study is yet to be peer reviewed and published. We have to see clinical benefit on the ground and also await regulatory approval,” said Dr Anoop Amarnath, head, Scientific Board and chairman, Geriatric Medicine, Manipal Hospitals.

    In India, five companies are conducting trials for this drug — Cipla, Dr Reddy’s, Emcure, Sun Pharma and Torrent.

  • Phase 3 trial of new Covid drug at Apollo, elsewhere

    By Express News Service
    NEW DELHI:  Phase 3 clinical trials in nearly 2,400 people in India have begun to test the efficacy of experimental antiviral drug Molnupiravir against Covid-19, following regulatory approvals by the Central Drug Standard Control Organisation. 

    This drug, developed by Merck originally, is an oral broad spectrum antiviral agent that has shown promise in treating mild and moderate Covid cases in early-stage trials in some countries. In India, five companies have entered into voluntary licensing agreements to produce generic versions of it. And MSN laboratories has received permission to conduct the trials. 

    Dr Suneetha Narreddy, senior consultant, infectious diseases, at Apollo Hospital in Hyderabad, which is one of the 40 sites in India where the phase 3 trials will be held, said that the drug is showing promise.“Data from early stage trials and preliminary analysis of phase 3 trials from outside India looks very promising but we should wait till the trials are concluded in India to say something definitive,” she said, adding it is being given to non-hospitalised patients with mild and moderate disease. 

    “Final analysis will depend on how many of the patients with or without this drug in the placebo and treatment arm go on to develop severe disease or needed hospitalisation.”