AbbVie Receive the CHMP's Positive Opinion Recommending Approval of Rinvoq (upadacitinib) for Atopic Dermatitis
Shots:
- The opinion is based on data from the 3 P-III studies i.e Measure Up 1- Measure Up 2 & AD Up evaluating the safety & efficacy of Rinvoq (15/30 mg- qd) with & without TCS vs PBO in 2-500+ patients with AD who were candidates for systemic therapy
- The studies met all 1EP & 2Eps i.e Rinvoq (for both doses) showed an improvement in skin clearance & reduction in itch @16wks. & other time points. The company expects to get EC’s approval in Q3’21
- If approved- therapy marks 4th indication & will be 1st JAK inhibitor in the EU for AD in adults & adolescents aged >12yrs. The MAA will be valid in all member states of the EU- Iceland- Liechtenstein- Norway & Northern Ireland
| Ref: Abbvie | Image: abbvie
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