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Welcome

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Apologies

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Declaration of conflicts of interest

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Applications for consent to distribute a new medicine under section 23 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

4.1

Paxlovid (nirmatrelvir), film coated tablet, 150mg/100mg (Pfizer New Zealand Ltd)

This product is a prescription medicine proposed for the treatment of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The proposed indication for Paxlovid is the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death.

Paxlovid consists of two different film-coated tablets packaged together. One tablet contains the novel antiviral active ingredient nirmatrelvir, which is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (Mpro) and prevents viral replication. The other tablet contains the previously approved antiviral active ingredient ritonavir, which in inhibits CYP3A-mediated metabolism of nirmatrelvir. The tablets contain well established excipients and are co-packaged in blister packs.

The application was accepted by Medsafe on 10 November 2021. The application has undergone two rounds of requests for information. The application is being considered for provisional consent under section 23 of the Medicines Act 1981 with proposed conditions.

The application is being referred to the Committee for independent advice as to whether the Minister of Health should grant provisional consent for the proposed indications. The Committee is also asked to consider the appropriateness of the conditions and duration proposed for consent.

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General business

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Date of next meeting