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.