Palivizumab

• This winter, we’re having to get our heads around another respiratory virus – RSV.
• It’s less well known than COVID or flu, but it’s also responsible for unplanned visits to the GP or emergency department, and days off school, childcare and work.

What is RSV?

• This common respiratory virus usually causes a mild cold with symptoms such as a fever, runny nose, coughing, decreased appetite and a wheeze.
• Adults can be infected infected with RSV but usually recover in a few days.
• But in young babies RSV can cause more severe respiratory illnesses such as pneumonia or bronchiolitis.

Who’s most at risk?

• First Nations children are three to six times more likely to be hospitalised with bronchiolitis caused by RSV than non-First Nations children.
• Otherwise healthy children under 12 months old (usually under six months old) are the ones most often admitted to hospital.

Why are we seeing so many cases now?

• But measures earlier in the COVID pandemic limited the spread of RSV.
• However, many states are experiencing a winter surge in cases and hospitalisations attributed to it this year – bigger than before the pandemic.
• However, reduced immunity in young infants due to lower maternal and infant exposure may have contributed to the record number of cases.

Is there a vaccine?

• Australia’s only currently available preventative medicine is palivizumab, which is a long-acting monoclonal antibody given monthly during the RSV season.
• Due to its cost, it is reserved for infants at highest risk for severe RSV infection and is usually given in hospital.
• In May this year, the US Food and Drug Administration approved the RSV vaccine Arexvy for people aged 60 and over.

How can I protect my children in the meantime?

• Encourage children to cover their mouths and noses when coughing or sneezing, and regularly wash their hands.
• Ensuring kids stay away from school, childcare or other children when sick helps prevent the spread of many viruses, including RSV.
• If parents notice these signs or are worried about their child they should seek urgent medical assessment and not delay.

• Nirsevimab would be the first broadly protective option against RSV disease designed for all infants, if approved
  Paris, January 5, 2023.
• The Prescription Drug User Fee Act date, the FDA target action date for their decision, is in the third quarter of 2023.
• “This is a landmark file acceptance in the US as it brings us one step closer to offering the first and only broadly protective option against RSV disease designed for all infants.
• Nirsevimab also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.7-9

• This positive CHMP opinion underscores Beyfortus potential as a ground-breaking, first-in-class passive immunization that could transform the medical communitys approach to RSV prevention in infants.
• Beyfortus has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent LRTI caused by RSV.
• Between November 2016 and December 2017, 1,453 infants were randomized (Beyfortus, n=969; placebo, n=484) at the RSV season start.
• Infants were randomized (2:1) to receive a single 50mg (in infants weighing

• The Bronchiolitis market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted Bronchiolitis symptoms market size from 2018 to 2030 segmented by seven major markets.
• The report also covers current Bronchiolitis symptoms treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities.
• The drug chapter segment of the report encloses detailed analysis of Bronchiolitis marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Bronchiolitis.