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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

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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). 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.”

- ENDS -

Media Contact

For further information or to request an interview, please contact:

Hamish Walsh

Account Manager

Palin Communications

hamish@palin.com.au

0422 424 338

Ruth Heenan

Senior Manager – Asia Pacific Communications, Seqirus

Ruth.Heenan@seqirus.com

0416 565 332

 

PBS Information: This product is not funded on the Pharmaceutical Benefits Scheme

Consumer Medical Information available at www.seqirus.com.au/products

About hay fever 
Allergic rhinitis, commonly known as hay fever, affects more than 4.6 million Australians. Despite its common name, allergic rhinitis is not caused by hay and does not result in fever. It 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). People who are sensitive to these allergens may then experience symptoms such as an itchy and runny nose, sneezing, itchy and watery eyes, congestion and snoring.5

Hay fever is classified into seasonal (intermittent) and perennial (year-round) types. However, patients allergic to seasonal allergens, such as tree, grass or weed pollens, may still have symptoms for much of the year. For example, this may be the case in patients who are sensitised to multiple allergens or can occur in regions of Australia, such as Queensland, where it can be very difficult to define the pollen season.14

About Seqirus
Seqirus, a CSL company, is a leading provider of essential vaccines and pharmaceuticals. We have served Australia’s healthcare needs for over a century and today we develop, manufacture and source medicines that support the health and wellbeing of many thousands of people around the world.

About Ryaltris 
Ryaltris® is a combination nasal spray containing an antihistamine and a corticosteroid (olopatadine hydrochloride and mometasone furoate), indicated for the treatment of symptoms associated with allergic rhinitis and rhino-conjunctivitis in patients 6 years of age and older. Ryaltris Consumer Medicine Information can be found here

Australia was the first country to approve Ryaltris in 2019, when it was approved by the TGA for the symptomatic relief of patients aged 12 years and over with allergic rhinitis and rhinoconjunctivitis.

RYALTRIS® is a registered trademark of Glenmark Specialty SA. Seqirus (Australia) Pty Ltd. Melbourne, Victoria, Australia. ABN 66 120 398 067. Medical Information: 1800 642 865. ANZ-
RYAL-22-0004. Date of Preparation: February 2022.

References

Ryaltris Approved Product Information.

AIHW, Allergic Rhinitis (Hay Fever) 2020. Available at: https://www.aihw.gov.au/reports/chronic-respiratory-conditions/allergic-rhinitis-hay-fever/contents/allergic-rhinitis. Accessed February 2022.

Owens L, et al. J Asthma Allergy. 2018;11:173-180.

Mir E, et al. Asia Pac Allergy. 2012;2(2):93-100.

Australian Society of Clinical Immunology and Allergy, Allergic Rhinitis (Hay Fever) 2019. Available at: https://www.allergy.org.au/patients/allergic-rhinitis-hay-fever-and-sinusitis/allergic-rhinitis-or-hay-fever. Accessed February 2022.

Bosnic-Anticevich S, et al. BMJ Open 2020;10:e038870. 

Deliu M, et al. Allergy. 2014;69(11):1515-1521. 

Engel-Yeger B, et al. Int J Pediatr Otorhinlaryngol. 2010;74:1415–8.

Meltzer, E et al. Allergy and asthma proceedings 2009;30.244-54.

10 Hagemann, J et al .Allergy, 2021;76:2354-2366.

11 Goss et al. Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. 

12 Settipane RA. Allergy Asthma Proc. 1999 Jul-Aug;20(4):209-13.

13 Campbell, R. Aust J Otolaryngol 2021;4:31.

14 Bousquet J, et al. J Allergy Clin Immunol 2001; 108: S147-S334.