(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab) faces competition.
The drug, Rinvoq (upadacitinib), is a JAK inhibitor.
Rinvoq’s label has a warning that flags risks of serious infections and lymphoma. In a notice, the FDA also said that patients taking JAK inhibitors in general risked developing blood clots.1
AbbVie has been aggressively fending off competition for Humira by signing deals with rival companies to prevent their cheap versions of the drug from entering the U.S., its biggest market, until 2023.
Humira, which treats RA and psoriasis, is the world’s best-selling medicine and brought in global revenue of $4.87 billion in the second quarter. But sales have been falling as it faces competition from cheaper rivals in Europe.
To further diversify its pipeline, in June, AbbVie announced a deal to buy Botox-maker Allergan Plc. for $63 billion.
It has also launched a new psoriasis medicine, Skyrizi (risankizumab-rzaa), to help retain some market share.
Shares of the company rose 2.2% to $64.36 in early afternoon trade.
- U.S. Food and Drug Administration. Drugs: Highlights and prescribing information: Rinvoq (upadacitinib). 2019 Aug.