TGA Approves Pfizer’s Novel COVID-19 Oral Treatment in Australia

• Therapeutic Goods Administration (TGA) approves PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for supply to Australia.

• PAXLOVID is the first oral treatment of its kind; it includes nirmatrelvir, a 3CL (or main) protease inhibitor that was specifically designed to combat SARS-CoV-2.

• Pfizer Australia has entered an agreement with the Australian Government to supply 500,000 treatment courses over 2022.

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SYDNEY, AUSTRALIA, 20 January 2021 – Pfizer announced today that Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval for the supply and use in Australia of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets. PAXLOVID has provisional approval for 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 is the first oral antiviral of its kind; it includes nirmatrelvir, a 3CL protease (also known as Main protease or Mpro) inhibitor that was specifically developed in Pfizer’s laboratories to combat SARS-CoV-2. Under this authorisation, PAXLOVID can be prescribed as an oral treatment to certain high-risk adults within the first 5 days of symptomatic infection, potentially helping patients avoid severe illness which can lead to hospitalisation or death.

“This milestone in Australia is an important moment in our continued fight against COVID-19, paving the way for use of PAXLOVID as cases continue to rise and we address the threat of a new variant of concern, Omicron,” said Anne Harris, Pfizer Australia and New Zealand Managing Director. “This at-oral therapy, developed to reduce hospitalisations and save lives, has the potential to transform COVID-19 treatment and help lessen the devastating impact of the virus that has now taken over 5 million lives globally”, Ms Harris said.

The TGA based its decision on positive results from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis, which enrolled non-hospitalised adults with confirmed COVID-19 who were at increased risk of progressing to severe illness. The data demonstrated an 89% reduction in risk of COVID-19-related hospitalisation or death from any cause in adults treated with PAXLOVID compared to placebo in those treated within three days of symptom onset, with no deaths in the treatment group. Similar results were seen in those treated within five days of symptom onset. Treatment-emergent adverse events were comparable between PAXLOVID (19%) and placebo (21%), most of which were mild in intensity. Pfizer recently announced that results from the final analysis of the primary endpoint from all patients enrolled in EPIC-HR were consistent with the interim analysis, confirming efficacy with a similar safety profile. Additional Phase 2/3 clinical trials are ongoing in adults at standard risk of progressing to severe illness, and in those who have been exposed to the virus through household contacts.

In October 2021, Pfizer announced an agreement with the Australian Government to supply 500,000 treatment courses of PAXLOVID over 2022. With the oral treatment now approved for supply and use by the TGA, Pfizer will begin delivering the first treatment courses from Q1 2022.