TGA provisionally approves Merck Sharp & Dohme (Australia) Pty Ltd's oral COVID-19 treatment, LAGEVRIO (molnupiravir)

On 18 January 2022 the Therapeutic Goods Administration (TGA) granted provisional approval to Merck Sharp & Dohme (Australia) Pty Ltd for its oral COVID-19 treatment, LAGEVRIO (molnupiravir).

LAGEVRIO (molnupiravir) has been granted provisional approval for the treatment of 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.

LAGEVRIO is not intended to be used as a substitute for vaccination again COVID-19.

LAGEVRIO should be administered as soon as possible after diagnosis of COVID-19 and within 5 days of the start of symptoms. The medicine, which is available as capsules, should be taken twice a day for 5 days.

The use of LAGEVRIO is not recommended in pregnancy and breastfeeding. It is recommended that sexually active women of childbearing potential use contraception and men also use contraception during and 3 months after treatment with LAGEVRIO.

Molnupiravir is considered to have broad-spectrum activity against a range of RNA viruses including SARS-CoV-2, which causes COVID-19. Molnupiravir works by inhibiting replication of SARS-CoV-2.

LAGEVRIO has received conditional marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency and emergency use authorization from the US Food and Drug Administration.

Provisional approval of this treatment in Australia is subject to certain strict conditions, such as the requirement for the sponsors to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Australians can be confident that the TGA's review process of LAGEVRIO was rigorous. The decision to provisionally approve the medicine was informed by expert advice from the Advisory Committee on Medicines (ACM), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.

The Australian Government has secured an advanced purchase agreement for 300,000 courses of LAGEVRIO for supply in 2022, with the first deliveries of the medicines anticipated in the coming weeks.

Supporting regulatory documents

The provisional approval pathway provides a formal and transparent mechanism for registration of promising new medicines with preliminary clinical data.

The following regulatory documents are made available as part of this process:

• Product information (PI)
• Consumer Medicine Information (CMI)
• LAGEVRIO Decision Summary
  The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.
• AusPAR: Molnupiravir
  An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
• Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Merck Sharp and Dohme) (Molnupiravir) Labelling Exemption 2022