16 FEBRUARY 2024 ausdoc . com . au

Rachel Fieldhouse THE TGA has approved the first respiratory syncytial virus vaccine , Arexvy , with sponsor GSK Australia hinting it would “ soon ” be available on a private script for over-60s .

The company , which first sought approval for the protein-based vaccine in early 2023 , said the decision was based on results from its phase III trial involving 25,000 older adults .

Arexvy had an efficacy of 83 % against respiratory syncytial virus ( RSV ) -related lower respiratory tract disease compared with placebo .

Researchers said it was equally effective for patients aged 60-69 and 70-79 , as well as for those with COPD , chronic heart failure , diabetes , advanced liver or renal disease and other comorbidities .

While GSK Australia could not confirm when Arexvy would be available on the private market or the cost of the single-dose regimen , a spokesperson said it would be working with “ relevant stakeholders to provide equitable access ”.

The TGA ’ s decision last month was welcomed by infectious diseases experts , including Professor Robert Booy in Sydney , who said it represented “ a turning point ”.

Meanwhile , long-acting monoclonal antibody nirsevimab ( Beyfortus ) has also been approved for preventing RSV in children under two .

Although the TGA decision was made in November , drug sponsor Sanofi Australia said it would not be available to purchase privately .

“ While we cannot give further details at this time , we believe fully funded programs are needed so all infants have equitable access to Beyfortus , and we are making every effort to make this possible ,” a spokesperson said .

Phase III trial results , published in December , showed that one dose of nirsevimab was 76 % effective for preventing very severe RSV-associated respiratory tract infections in infants versus standard care .

It included 8100 healthy infants ( mean age 4.5 months ) entering their first RSV season in early 2022 . N Engl J Med 2023 ; 16 Feb ( Arexvy ). N Engl J Med 2023 ; 28 Dec ( nirsevimab ).

for your at-risk adult patients with mild to moderate COVID-19 1

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Demonstrated efficacy 1

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In MOVe-OUT , LAGEVRIO reduced risk for hospitalisation or death vs . placebo 1

( LAGEVRIO 6.8 % vs placebo 9.7 %, adjusted risk difference -3.0 % ( 95 % CI : -5.9 to -0.1 %)) in all randomised modified intent-to-treat populations who were not hospitalised with mild to moderate COVID-19 . The adjusted relative risk reduction of LAGEVRIO compared to placebo for all randomised subjects was 30 % ( 95 % CI : 1 %, 51 %, P value not available for final analysis , statistical power assigned to interim analysis ). 1 Based on a planned interim analysis : 7.3 % of patients who received LAGEVRIO were either hospitalised or died through Day 29 ( 28 / 385 ), vs 14.1 % of placebo ( 53 / 377 ). The adjusted risk difference was -6.8 % with a 95 % CI of ( -11.3 %, -2.4 %)

* No known drug interactions based on limited data available 1

and 2-sided p-value = 0.0024 . 1 For MOVe-OUT study design , please scan QR code located on the right .

This medicine is subject to additional monitoring in Australia . This will allow quick identification of new safety information . Healthcare professionals are asked to report any suspected adverse events at www . tga . gov . au / reporting-problems .

SELECTED SAFETY INFORMATION 1

INDICATION LAGEVRIO has 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 . The decision to approve this indication was based on efficacy and safety data from a Phase 3 trial . Continued approval of this indication depends on additional data .

CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients . Hypersensitivity reactions have been reported with LAGEVRIO . If signs or symptoms of a clinically significant hypersensitivity reaction occur , immediately discontinue LAGEVRIO and initiate appropriate medications and / or supportive care .

PRECAUTIONS : Pregnancy Category D : The use of LAGEVRIO is not recommended during pregnancy . 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 . Contraception : Advise women of childbearing potential to use effective contraception for the duration of treatment and for 4 days after the last dose of LAGEVRIO . 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 foetal harm when administered to pregnant women . Breastfeeding : Based on the potential for adverse reactions on the infant from LAGEVRIO , breastfeeding is not recommended during treatment and for 4 days after the last dose of LAGEVRIO . Paediatric patients : Use in patients under the age of 18 years is not recommended .

ADVERSE EVENTS Common : nausea , diarrhoea , dizziness . The following have been reported in post-marketing experience : hypersensitivity , angioedema , erythema , pruritus , rash , urticaria , vomiting .

PBS Information : Authority required ( STREAMLINED ). Please refer to www . pbs . gov . au for eligibility criteria . Before prescribing , please review the full Product Information available at www . msdinfo . com . au / lagevriopi or scan QR Code .

Copyright © 2023 Merck & Co ., Inc ., Rahway , 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 . MSDA0074 . AU-ANV-00446 . Issued November 2023 .

Simple * treatment choice

* No dose adjustments required in patients with renal or hepatic impairment 1

Demonstrated safety and tolerability profile 1

Treatment related adverse events ≥ 1 % ( LAGEVRIO vs placebo ): Diarrhoea ( 2 % vs 2 %); Nausea ( 1 % vs 1 %); Dizziness ( 1 % vs 1 %).