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AbbVie stirs safety jitters after two patients die in ABT-494 study

AbbVie $ABBV revealed that two rheumatoid arthritis patients died in its late-stage work on ABT-494, which quickly triggered a case of the jitters for a drug touted as a major part of the company’s late-stage pipeline hopes.

According to researchers, the two patient deaths include one for unknown causes. A second patient in the 30 mg dose group came down with a fever and had problems with diarrhea. The subject subsequently experienced heart failure and presumed pulmonary embolism.

AbbVie had focused hard on the positive efficacy data for this drug, now through two Phase III trials. The drug hit all major endpoints in this new study. The therapy is now dubbed upadacitinib.

Michael Severino

AbbVie’s shares took a hit on the news, dropping 1.2% after the market opened.

Just a few days ago AbbVie was touting stellar data for this drug in atopic dermatitis, which helped explain why it decided to take a pass on some big partnership deals to concentrate on its in-house program.

“We are very pleased with the positive results for upadacitinib in the SELECT-BEYOND trial. Particularly exciting is the proportion of patients who achieved clinical remission by week 12 and 24, despite having inadequate responses with previous biologic therapies,” said Michael Severino, Abbvie’s chief scientific officer.


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