AbbVie wins EU approval for two Rinvoq doses

• The European Commission (EC) has approved AbbVie's (NYSE:ABBV) RINVOQ (upadacitinib) to treat severe alopecia areata (AA) in adult and adolescent patients aged 12 and older.
• The approval is backed by the Phase 3 UP-AA clinical program, which demonstrated that RINVOQ is the first JAK inhibitor to achieve complete scalp hair regrowth versus placebo at week 24.
• RINVOQ will be available in 15 mg and 30 mg once-daily doses for this new indication across the European Union.

AbbVie (NYSE:ABBV) received European Commission approval for Rinvoq 15 mg and 30 mg to treat severe alopecia areata in patients aged 12 and older.

The decision follows a positive regulatory recommendation issued on June 29 and converts that opinion into marketing approval across the European Union.

“The European Commission’s approval of RINVOQ provides a new treatment option for the severe alopecia areata community in the EU,” said AbbVie executive vice president and chief scientific officer Roopal Thakkar.

The trials included 1,399 patients aged 12 to 64 across 248 sites, while the label carries warnings covering serious infections, malignancies, MACE and VTE.

Rinvoq already has EU approvals covering conditions including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, atopic dermatitis and non-segmental vitiligo.

AbbVie said US regulators are still reviewing Rinvoq for alopecia areata, while Phase 3 studies continue across three other immune-mediated diseases.