Logo

AbbVie Receive the CHMP's Positive Opinion Recommending Approval of Rinvoq (upadacitinib) for Atopic Dermatitis

Share this

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

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions