COVID-19 pill LAGEVRIO approved for use in Australia
January 20, 2022 7:46 am Australia/Sydney
MSD in Australia today announced that LAGEVRIO (molnupiravir) an oral antiviral treatment for adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death, has received provisional approval by the Therapeutic Goods Administration.1
LAGEVRIO will be made available in non-hospitalised settings, in line with the provisional approval, to treat eligible Australian patients with COVID-19 who are at risk of hospitalisation or death.1
LAGEVRIO is an oral antiviral for the first-line treatment of COVID-19 in adults at risk of hospitalisation or death.1 The therapy works by inserting itself into the viral RNA of COVID-19. As a result, the virus can no longer reproduce.1
Dr Gary Jankelowitz, Medical Director, MSD Australia says, “The provisional approval of this oral antiviral treatment for COVID-19 in eligible at-risk adults is a regulatory milestone in the ongoing fight against COVID-19.”
He adds, “LAGEVRIO has the potential to help address a medical need in the community. MSD acknowledges the partnership and support of the Australian Government and the Minister for Health and Aged Care, Hon Greg Hunt MP, in making this treatment option available for eligible adults.”
In October 2021, the Australian Government entered into an agreement with MSD to secure 300,000 treatment courses of LAGEVRIO once provisionally approved. LAGEVRIO will be supplied to the National Medical Stockpile in accordance with the terms of the agreement between MSD and the Australian Government.
Dr Paul Griffin, Infectious Disease Physician and Microbiologist at Mater Health, Brisbane, says “Taken twice daily for five days, access to this oral antiviral provides an additional option to Australia’s pandemic response. Importantly, this treatment allows the virus to be treated in community settings.”
He adds, “The availability of an oral treatment for eligible patients with mild-to-moderate disease will mean that patients will be able to be at home, and be actively treated. Vaccination is still the number one line of defence against COVID-19, but we need multiple defences against the virus, including treatments for those who are at high risk for progression to severe disease.”
LAGEVRIO should be administered as soon as possible after diagnosis of COVID-19 has been made and within 5 days of symptom onset in eligible adults. The provisional approval is based on the Phase 3 MOVe-OUT global trial, which evaluated LAGEVRIO compared to placebo in adult patients who were unvaccinated against SARS-CoV-2, had confirmed SARS-CoV-2 infection no more than five days earlier, symptom onset within five days of study randomisation, and at least one risk factor associated with poor disease outcomes including age >60 years, obesity, diabetes, or cardiovascular disease.1,2
All medicines carry the risk of side-effects. In clinical trials, the most common adverse events associated with LAGEVRIO treatment were diarrhoea, nausea and dizziness.1
LAGEVRIO Selected Safety Information.1
PRECAUTIONS: Pregnancy Category D; The use of LAGEVRIO is not recommended during pregnancy and breastfeeding. In women of childbearing potential, health care providers should discuss the chance that they may be pregnant and consider the need for a pregnancy test. Advise women of childbearing potential to use effective contraception for the duration of treatment and for 4 days after the last dose of LAGEVRIO (molnupiravir). Sexually active men with a partner of childbearing potential should use contraception during and for 3 months after treatment. Based on animal data, LAGEVRIO may cause fetal harm when administered to pregnant women. Paediatric patients: Use in children is not recommended. Use in elderly: No dose adjustment of LAGEVRIO is recommended based on age. INTERACTIONS: No drug interactions have been identified based on the limited available data. CONTRAINDICATIONS: Hypersensitivity to the active substance or any of the excipients. ADVERSE REACTIONS. The most common adverse reactions occurring in ≥1% of subjects in the molnupiravir treatment group in the Phase 3 double-blind MOVe-OUT study were diarrhoea (2% versus placebo at 2%), nausea (1% versus placebo at 1%), and dizziness (1% versus placebo at 1%) all of which were Grade 1 (mild) or Grade 2 (moderate). Serious adverse events occurred in 7% of subjects receiving molnupiravir and 10% receiving placebo; most serious adverse events were COVID-19 related. Adverse events leading to death occurred in 2 (<1%) of the subjects receiving molnupiravir and 12 (2%) of subjects receiving placebo.
In October 2021, the Australian Government entered into an agreement with MSD to secure 300,000 treatment courses of LAGEVRIO once provisionally approved. The Australian Government will determine access to LAGEVRIO for eligible adults.
For more information on LAGEVRIO, consult a healthcare professional. The Consumer Medicines Information leaflet is available online.
LAGEVRIO has received provisional approval. The decision to approve this indication has been made on the basis of the analysis of efficacy and safety data from a Phase 3 trial. Continued approval of this indication depends on additional data.
B-roll and photography relating to molnupiravir are available at:
Copyright © 2022 Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited. Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113. AU-ANV-00053. Issued 20 January 2022.
- LAGEVRIO PI. January 2022
- Jayk Bernal A, Gomes da Silva MM, Musungaie DB, et al. Molnupiravir for oral treatment of Covid-19 in nonhospitalized patients. N Engl J Med. DOI: 10.1056/NEJMoa2116044.