AbbVie stock collapsed to a five-month low Wednesday after the Food and Drug Administration said it would have to add a warning to the label for arthritis drug Rinvoq.
The order also applies to drugs from Pfizer (PFE) and Eli Lilly (LLY). All three treat inflammatory conditions arthritis and ulcerative colitis. The companies must warn users of AbbVie‘s (ABBV) Rinvoq, Pfizer’s Xeljanz and Lilly’s Olumiant that they come with an increased risk of heart-related events, cancer, blood clots and death.
In midday trading on today’s stock market, AbbVie stock plunged 8.6% near 110.40. Pfizer stock toppled 0.9% near 45.70. Lilly stock fell 0.5% near 257.
AbbVie Stock Falls On FDA Order
Rinvoq, Xeljanz and Olumiant belong to the same class of drugs — janus kinase inhibitors, or JAK inhibitors. These drugs modify the immune system’s inflammatory response.
A post-approval study pitted Pfizer’s Xeljanz against another drug class in rheumatoid arthritis patients. The other drugs block a substance in the body that causes inflammation called tumor necrosis factor, or TNF. The test showed an increased risk of blood clots and death with a low dose of Xeljanz. Previously, officials thought only a higher dose of Xeljanz would heighten those risks.
The FDA required new and updated warning labels on all three JAK inhibitors in arthritis treatment — hurting AbbVie stock, in particular. The agency noted Olumiant and Rinvoq hadn’t been studied in large safety tests with Xeljanz “so the risks have not been adequately evaluated.”
“However, since they share mechanisms of action with Xeljanz, FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial,” the agency said in a news release.
Rinvoq: The Next Humira?
AbbVie stock is susceptible to swings in opinion on Rinvoq. The company’s bread-and-butter drug is TNF blocker Humira. Humira treats a number of inflammatory issues, including types of arthritis. But it’s set to face biosimilar rivals in the U.S. in 2023. Rinvoq won’t see copycat rivals for some time.
The FDA also noted the warning label requirement doesn’t apply to JAK inhibitors from Bristol Myers Squibb (BMY) and Incyte (INCY) known as Inrebic and Jakafi, respectively. These drugs treat blood disorders and aren’t being used in arthritis or for other inflammatory conditions.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
YOU MAY ALSO LIKE: