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News & Trends - Pharmaceuticals

Australia secures access to two new COVID treatments from Roche and Pfizer

Health Industry Hub | October 18, 2021 |
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Pharma News: The Australian Government has secured access to two additional COVID-19 treatments to support the National Plan to Transition Australia’s COVID-19 response.

Under a new agreement with Roche Products, 15,000 doses of the COVID-19 antibody-based therapy Ronapreve (combination of monoclonal antibodies casirivimab and imdevimab) has been secured.

The first supply of this treatment is expected to be available by the end of this month through an initial shipment of 5,000 doses and will be held in the National Medical Stockpile.

Ronapreve can be administered intravenously for COVID-19 patients in a healthcare facility and is expected to be targeted for use in unvaccinated people who are at risk of developing severe disease.

A Roche spokesperson said “Roche Australia welcomes the provisional approval of the antibody combination casirivimab and imdevimab (Ronapreve). The ongoing partnership between Roche and Regeneron leverages Roche’s leading expertise in developing, manufacturing, supplying and distributing innovative medicines, and is an important example of how Roche as a company, industry and society can successfully work together during this public health crisis.”

The efficacy of Ronapreve is based on two pivotal clinical trials. The first randomised 4,567 outpatients with COVID-19 to placebo or intravenous Ronapreve. One-off treatment with 1200 mg or 2400 mg Ronapreve reduced the composite primary outcome of hospital admission or death by around 70% P=0.0024 for 1200 mg; P<0.0001 for 2400 mg) and the median time to symptom resolution from 14 to 10 days.

The second trial evaluated prophylactic subcutaneous administration of 1200 mg Ronapreve versus placebo in people without antibodies to COVID-19 who had been exposed to SARS-CoV-2 by someone in their household. Those who initially had a negative PCR result were less likely to develop disease when administered Ronapreve within 96 hours of contact (relative risk reduction 66%, P<0.001), while any consequent symptomatic infections also resolved faster (1.2 weeks versus 3.2 weeks). In asymptomatic individuals with an initial positive PCR result, treatment with Ronapreve reduced the development of symptomatic disease by 31% (P<0.038).

In addition, the Australian Government has secured access to 500,000 treatment courses of Pfizer’s COVID-19 oral antiviral drug PF-07321332, to be used in combination with AbbVie’s protease inhibitor drug ritonavir, subject to regulatory approval by the Therapeutic Goods Administration (TGA).

Anne Harris, Pfizer Australia and New Zealand Managing Director, said “We are honoured to work with the Australian Government toward achieving our shared goal of addressing this public health crisis. If successful, oral antiviral therapies such as protease inhibitors may help to reduce the severity or onset of illness in adults who contract, or have been exposed to, COVID-19. An oral treatment option may thus be an important potential tool to help address the ongoing global impact of the COVID-19 pandemic.”

This treatment which is still undergoing clinical trials is expected to help to reduce the severity or onset of illness in adults who contract, or have been exposed to, COVID-19. It is expected to be available over the course of 2022, subject to final clinical trials being completed by Pfizer and the necessary TGA approval process. This oral antiviral treatment is taken every 12 hours for five days and is designed to block an enzyme the virus needs in order to multiply early in its lifecycle.

The EPIC (Evaluation of Protease Inhibition for COVID-19) Phase 2/3 development program for PF-07321332 consists of multiple ongoing clinical trials: one in SARS-CoV-2 infected patients who are at high risk of severe illness (including hospitalisation or death), a second in infected, symptomatic patients who are at standard risk, and a third aimed at preventing development of SARS-CoV-2 infections in adult household contacts of symptomatic COVID-19 patients.

On 1 October 2021, the TGA granted provisional determination to Pfizer Australia in relation to this treatment which means that Pfizer can apply to the TGA for approval through this fast track approval process once the clinical trials are complete.

Additionally, following regulatory approval by the TGA, Roche’s Ronapreve will join other COVID-19 treatments including GSK’s Xevudy (sotrovimab) and Gilead’s Veklury (remdesivir) that are already available to healthcare professionals through the National Medical Stockpile to help treat people with COVID-19. 

Australia has also secured an advanced purchase agreement for 300,000 courses of the promising oral COVID-19 treatment MSD’s molnupiravir for supply in 2022 subject to TGA approval.


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