- FDA said makers of janus kinase inhibitors, or JAK inhibitors, would have to warn users against a myriad of conditions. The requirement impacts AbbVie's Rinvoq, Pfizer's Xeljanz and Lilly's Olumiant. All three are JAK inhibitors for arthritis and other inflammatory conditions.
The order also impacts drugs from Pfizer (PFE) and Eli Lilly (LLY). A recent test of Pfizer's Xeljanz indicated the drug increases the risk of heart issues, blood clots, cancer and death in patients treated for arthritis and other inflammatory conditions. AbbVie's (ABBV) Rinvoq and Lilly's Olumiant belong to the same drug class.
Recently, AbbVie said it plans to test a next-generation version of Alzheimer's drug Aduhelm beginning late this year or early next. Aduhelm, a Biogen (BIIB) drug, gained approval in June and helped shift researchers' focus to the beta amyloid theory of treatment.
Beta amyloid is a type of plaque that builds up in the brains of Alzheimer's patients. Some believe removing it will help improve patients' cognition. The theory doesn't have full support from the scientific community, however. On the company's second-quarter earnings call, AbbVie President Michael Severino said the company had monitored this area for several years.
Seeking Diversity From Humira
A number of companies have launched Humira biosimilars in Europe and plan to launch those same copycats in the U.S. in 2023. That's problematic for AbbVie stock. Humira accounted for more than 43% of adjusted sales in 2020.
In the U.S., Humira grew 19.2%. But biosimilars chipped away at international sales, which fell 7.9% on a strict as-reported basis. Overall, first-quarter Humira sales rose 3.5%.
Total sales surged 37.6% in 2020, hitting $45.78 billion. But that includes the takeover of Botox-maker Allergan. On a comparable operational basis, sales inched up 3.3%.
On May 18, CEO Gonzalez faced questions from the Oversight and Reform Committee regarding the company's pricing and patent practices for Humira. Gonzalez acknowledged Humira costs more in the U.S. than it does in socialized health care systems abroad.
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.
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