Please ensure Javascript is enabled for purposes of website accessibility

Should AbbVie Be Worried About Rinvoq?

By Keith Speights and Brian Orelli, PhD - Apr 14, 2021 at 6:01AM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

There's more reason to be concerned than in the past.

The U.S. Food and Drug Administration (FDA) has now pushed back two reviews for regulatory filings by AbbVie (ABBV 0.09%) for Rinvoq. This autoimmune disease drug is an important component of the company's growth strategy. In this Motley Fool Live video, recorded on April 7, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss whether or not AbbVie and its shareholders should be worried about Rinvoq.

Keith Speights: AbbVie -- ticker there's ABBV. AbbVie announced on April 2 that the FDA has pushed back the review period for Rinvoq in treating atopic dermatitis by three months. Now the FDA had already extended the review period for this drug in treating psoriatic arthritis just a few weeks ago making that announcement.

Now, AbbVie's counting on Rinvoq to be a key part of its strategy to offset the expected decline in sales for Humira when that top-selling drug loses patent exclusivity in 2023. Brian, do you think the company or investors should be worried about Rinvoq now?

Brian Orelli: We knew this was coming because AbbVie disclosed it when the psoriatic arthritis delay happened a few weeks ago. They said they were expecting it. It's not really new, but it's definitely a worry nonetheless.

I think the biggest concern here is if the FDA delays due to reviewing an updated benefit-risk profile that AbbVie had to submit. The benefit hasn't really changed since the clinical trial. Really, the issue here is specifically the risk in the entire class of drugs.

This is a JAK inhibitor, Pfizer's Xeljanz saw an increased risk of serious heart-related issues and cancer in their clinical trial. As you said, AbbVie is really counting on Rinvoq to make up for lost sales for Humira and I think this is a major issue for AbbVie.

We'll have to wait and see exactly what the FDA does. We're just talking about a black box warning when we're talking about something more serious where they limit the number of patients that can take the drug to maybe only the most severe patients, or are we talking about even worse where they want to improve the drug?

Speights: Yeah. You made a good point, Brian, that this is a bigger issue than just Rinvoq. This is an issue for the entire category of JAK inhibitors. I saw this morning that Eli Lilly and Incyte announced that the FDA is pushing back the review period for Olumiant in atopic dermatitis, I think that was the indication. It's also a JAK inhibitor. I think the FDA is really taking its time on the reviews of any JAK inhibitors right now.

Orelli: The other problem here is that atopic dermatitis is not really the most severe disease. If you're treating cancer, you're allowed to have a lot more severe side effects than if you're treating a skin disease, where you're not going to die from atopic dermatitis. It's annoying and it doesn't look good and itches. I live with somebody with atopic dermatitis [laughs] so I know the feeling, but you're not going to die from it. That limits the side effects that the FDA is going to be willing to accept.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

AbbVie Inc. Stock Quote
AbbVie Inc.
ABBV
$153.93 (0.09%) $0.13
Eli Lilly and Company Stock Quote
Eli Lilly and Company
LLY
$327.18 (0.76%) $2.47
Pfizer Inc. Stock Quote
Pfizer Inc.
PFE
$51.64 (-1.28%) $0.67
Incyte Corporation Stock Quote
Incyte Corporation
INCY
$79.25 (2.03%) $1.58

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
316%
 
S&P 500 Returns
112%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 07/05/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.