Shionogi & Co., Ltd.
Regarding the Application for Manufacturing and Marketing Approval for the Addition of Lotion Formulation of Atopic Dermatitis Treatment “Collectim®” in Japan
Shionogi & Co., Ltd. has applied for manufacturing and marketing approval of the 0.5% lotion formulation of the atopic dermatitis treatment "Collectim®." Safety and bioequivalence were confirmed through Phase 1 skin safety and Phase 3 bioequivalence studies.
Key Figures
- Lotion Concentration: 0.5%
- Phase 1 Skin Safety Study: Confirmed favorable safety
- Phase 3 Bioequivalence Study: Confirmed bioequivalence with ointment formulation
AI要約
Product Overview and Application Details
Shionogi & Co., Ltd. and Torii Pharmaceutical Co., Ltd. have applied for manufacturing and marketing approval of the 0.5% lotion formulation as a new dosage form of the atopic dermatitis treatment "Collectim®." Collectim® is a JAK inhibitor that is already approved as an ointment for atopic dermatitis in adults, children, and infants. This lotion formulation has confirmed bioequivalence with the ointment and features easy application to the scalp and hairy areas.
Clinical Trial Results and Future Outlook
Safety and bioequivalence were confirmed as favorable in Phase 1 skin safety and Phase 3 bioequivalence studies. The lotion has a less sticky texture and favorable usability, expected to contribute to improved patient treatment adherence. Shionogi aims to enhance patients’ quality of life and is committed to early product availability.
