Combination nasal spray Ryaltris now approved for Australian children aged six years and older with hay fever or other year-round

Seqirus

Combination nasal spray Ryaltris® (olopatadine hydrochloride and mometasone furoate) now approved for Australian children aged six years and older with hay fever or other year-round allergies

· Australia is the first major country to approve Ryaltris for use in patients six years and older, after first receiving approval for 12 years and older in 2019.1

· More than 4.6 million Australians are affected by hay fever, with up to 18% of children affected by 11 years of age.2,3

· Children with hay fever may experience irritability, distraction, fatigue, embarrassment and increased days off school, making them more likely to have poorer grades than other students.4

MELBOURNE, 4 April 2022

Seqirus has confirmed that its combination antihistamine and steroid nasal spray, Ryaltris, is now available in Australia as a private prescription for the treatment of symptoms associated with allergic rhinitis and rhino-conjunctivitis, more commonly known as hay fever, in patients aged six years and older.1

Previously approved for use in patients aged 12 years and older, this new indication demonstrates the role of Ryaltris in helping to address the unmet needs of children affected by hay fever or other year-round allergies.

Hay fever is caused by the nose or eyes coming in contact with environmental allergens, such as pollens, dust mites, moulds, and animal dander (skin cells shed by animals).5 People who are sensitive to these allergens may experience symptoms such as an itchy and/or runny nose, sneezing, itchy and/or watery eyes, congestion and snoring.5

More than 4.6 million Australians are affected by hay fever, with 10% of cases occurring in children aged 14 and under.2

Australian studies have shown that children with hay fever are significantly more likely to visit their doctor for cough, respiratory tract infections and asthma and undergo more ear, nose and throat procedures than those without the condition.6

Children with hay fever are also nine-times more likely to miss school than those without the condition and may be less willing to engage in sports and social activities.7,8

Professor Richard Harvey, leading Rhinologist and Professor at both the University of NSW and Macquarie University, said that treatment may help restore patients’ ability to engage in daily activities.

“Hay fever is often considered a ‘nuisance condition’ but this is far from the experience of many patients. It can greatly impact quality of life, leading to impaired performance of daily activities, cognitive function, work and classroom productivity, poorer sleep quality and reduced psychosocial wellbeing,” said Professor Harvey.9

“Children aged six-to-eleven-years old are an important group for the new onset of hay fever symptoms, so it’s important that we can target them with effective treatment. If left untreated, children with hay fever may experience irritability, distraction, fatigue, embarrassment and increased days off school, making them more likely to have poorer grades than other students.”4

“In an environment where Australians are keenly aware of respiratory symptoms, uncontrolled hay fever can further impact children. Some hay fever symptoms, such as cough, fatigue and blocked or stuffy nose, may present similarly to COVID-19, resulting in testing and more missed school days. With better symptom control, we can help reduce the likelihood that children will be sent home from school unnecessarily.”10

Associate Professor Raewyn Campbell, leading Rhinologist and Associate Professor at Macquarie University, said that children with hay fever may also experience significant comorbidities following diagnosis.

“Hay fever is one of the most common chronic medical conditions in Australia so this approval is very welcome news for healthcare professionals and their patients,” said A/Prof Campbell.

“The incidence of hay fever increases significantly between the ages of six and eleven which is a critical developmental period for children. Having more treatment options available for this group of patients is so important. In particular, a combined treatment in the form of a nasal spray can be more convenient for children and their parents than using multiple single therapies.”3,11

“Poorly controlled hay fever may be associated with a variety of complications and respiratory conditions. Children should use their noses to breathe, however those with allergic rhinitis may instead rely on mouth breathing as their noses are blocked. This can lead to changes in their sleep quality, dentition, facial development and can also negatively impact their cognition and academic performance. Hay fever also usually precedes and is a significant risk factor for asthma.”12,13

“Managing allergic rhinitis may alleviate or prevent many of these problems and this is particularly important in children.”

Dr Jonathan Anderson, Seqirus Head of Medical Affairs Asia Pacific, said today’s announcement is an important milestone for Australians affected by hay fever.

“Australia is the first major country in the world to approve Ryaltris for the treatment of patients aged six years and older. Our world-class regulators have ensured that Australians continue to be first in line to be able to access new treatment options for hay fever,” said Dr Anderson.

“Seqirus is committed to helping address unmet patient needs and improve quality of life for Australians living with hay fever and today’s announcement is evidence of that.”

/Public Release.