EC approves AbbVie's Skyrizi for Crohn's disease

In another boost for AbbVie (NYSE: ABBV), the European Commission (EC) has granted a third approval of Skyrizi (risankizumab, 600mg intravenous [IV] induction and 360mg subcutaneous [SC] for maintenance therapy), this time as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

Developed as part of a collaboration between the US pharma major and family-owned German drugmaker Boehringer Ingelheim, Skyrizi is already registering blockbuster sales, with third-quarter revenues of almost $1.4 billion, up 75% year on year, and set to exceed the $8 billion annual forecast by analysts.

Skyrizi, along with AbbVie’s JAK blocker Rinvoq (upadacitinib), are expected to help fill the sales gap for AbbVie’s mega blockbuster Humira (adalimumab) - with annual revenues of more than $20 billion, which is already facing competition in Europe since patent expiry, but will face a big hit in the USA, where several biosimilars are cleared for marketing starting in the summer next year.