Shionogi & Co., Ltd.
Vitarama® Cream: Domestic pediatric atopic dermatitis indication addition approval
Obtained domestic manufacturing and sales approval for Vitarama Cream 0.5% for pediatric atopic dermatitis. Target age is 2 years and older to under 12 years; demonstrated superiority in efficacy and long-term safety compared with vehicle cream. Expected to have a minor impact on consolidated results for the fiscal year ending March 2027.
Key Figures
- Target market: approval for pediatric use (2 years to under 12 years)
- Long-term safety evaluation period: up to 60 weeks
- Existing approval: Vitarama Cream 1% indicates use for ages 12 and above
AI要約
Overview of the approval news
Announced the domestic manufacturing and sales approval of Vitarama Cream 0.5% for pediatric atopic dermatitis in children aged 2 years to under 12 years. The previously approved 1% product covers adults and children 12 years and older. The new approval demonstrates efficacy at 8 weeks and long-term safety up to 60 weeks, showing superiority to the base cream.
Outlook and implications
This approval is expected to broaden treatment options for pediatric patients. It aligns with the SHIONOGI Group's commitment to contributing to healthy and fulfilling lives as a material priority. The impact on the FY ending March 2027 is considered minor.
塩野義製薬株式會社
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