LOGO
LOGO

Quick Facts

AbbVie Seeking FDA And EMA Approval For Upadacitinib In Giant Cell Arteritis

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

AbbVie, Inc. (ABBV) announced Friday that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA).

GCA is an autoimmune disease of medium and large arteries and can cause headache, jaw pain, and changes in vision, including sudden and permanent loss of vision.

The regulatory submissions to the FDA and EMA are supported by previously announced results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of upadacitinib in patients with GCA.

For comments and feedback contact: editorial@rttnews.com

Business News

Global Economics Weekly Update: April 13 – April 17, 2026

April 17, 2026 15:29 ET
The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.