CRED NPM

05/11/2024

Internal

WHY? The importance of Seasonal Allergic Rhinitis (SAR) treatment

• AR affects 26% of adults in the UK and 20% in France. 48% of them struggle to perform at their best. • SAR has important impacts on quality of life and the ability of individuals to perform normal daily activities for work or study, as well as in exercise and leisure pursuits. • Prompt treatment reduces interference with daily life. • No new oral antihistamine OTC treatments launched in the UK and in France market for 30 and 18 years respectively → 8/10 people treat for AR but aren’t completely satisfied with symptomatic relief.

Fexofenadine was introduced in the 1990s, but in 2019 it remained the last in class among this category to be reclassified.

Reclassifying fexofenadine 120 mg to nonprescription drug would lead to a new therapeutic alternative to address unmet needs of all SAR sufferers

The Organisation for Professionals in Regulatory Affairs

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Internal

Rationale for the switch

Considering the benefits that fexofenadine’s reclassification will bring, we asked ourselves the following questions to prepare the application:

➢ Does this self category already exist? Yes

➢ Can the condition be self diagnosed? Yes

➢ Is there sufficient understanding of the condition? Yes

➢ Is the product simple to use? Yes

➢ Are the instructions for use simple to use? Readability user test

The Organisation for Professionals in Regulatory Affairs

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