AbbVie's post-Humira stalwarts Skyrizi, Rinvoq performing exactly as hoped, CEO says

AbbVie said it expects the FDA to make its decision over JAK inhibitor Rinvoq in the coming months. (AbbVie)

AbbVie is relying on its next-gen immunology drugs Skyrizi and Rinvoq to fill what will be a massive sales gap once blockbuster Humira faces generic foes in the U.S. And as the company sees it, everything is going according to plan. 

As those meds start to take off, the Chicago-based pharma expects the pair to pull in a combined $4.6 billion this year, CEO Richard Gonzalez said on Friday.

AbbVie is inching toward what will be the largest-ever patent cliff once Humira, the globe’s top selling drug, faces biosimilar competition in 2023. The company’s immunology heavyweight managed to rake in $4.26 billion in U.S. sales during the second quarter, up just over 7% compared with last year. European copycats are already starting to weigh down on international sales, which fell 6%. 

RELATED: AbbVie exec details upbeat plan for Rinvoq, Skyrizi as Humira copycats near: analyst

On the other hand, Skyrizi and Rinvoq revenues skyrocketed in the second quarter. Both drugs pulled off two-fold increases compared with the same quarter last year, with Skyrizi generating $674 million globally and Rinvoq clasping $378 million. 

“They’re rapidly growing, and they’re doing exactly what we hoped they would do,” Gonzalez told analysts on the company’s second quarter earnings call Friday. “They will buffer the [Humira] biosimilar impact in the U.S.” 

Part of AbbVie’s plan is to push those two treatments through a host of indications, Gonzalez said, although the company has faced some hurdles on that front recently, particularly with JAK inhibitor Rinvoq. 

The FDA has delayed its decision on a number of drugs in the JAK class entirely over safety concerns shrouding Pfizer’s Xeljanz, which turned up risks for dangerous heart side effects and cancer in a post-marketing study. 

RELATED: AbbVie's Rinvoq marches toward blockbuster ulcerative colitis nod even as JAK delays drag on

For Rinvoq, its applications in psoriatic arthritis, atopic dermatitis and ankylosing spondylitis have all been delayed. When asked about the FDA’s hold up, AbbVie’s vice chairman and president, Michael Severino, told analysts the company believes the agency could make a decision in the next few months. 

To be sure, the FDA hasn’t asked AbbVie to supply any additional safety data to support its applications. The current holdup is solely limited to the agency’s review of Xeljanz, Severino said. 

“I think once that’s completed, we would be able to move forward with good speed with our review,” Severino said. 

In the meantime, AbbVie has seen a surprisingly quick improvement for its wrinkle treatment Botox after pandemic lockdowns lifted. The company raised its full-year earnings forecast based on stronger-than-expand demand for the blockbuster wrinkle treatment, saying it now expects its aesthetic business to bring in nearly $5 billion this year. 

When it comes to Botox demand, Gonzalez doesn’t see it as a one-off from pent up pandemic demand. AbbVie thinks it’s growth can be sustained, the CEO said. 

“We believe this business is significantly under penetrated,” Gonzalez said. “When you look at the available patient population here and your ability to drive long-term penetration, it’s tremendous.