AbbVie's Skyrizi becomes first drug to win FDA nod for Crohn's disease

AbbVie (NYSE:ABBV) has announced that FDA has approved Skyrizi (risankizumab-rzaa) as the first interleukin-23 (IL-23) inhibitor to treat adults with moderately to severely active Crohn’s disease (CD).

Skyrizi is also FDA-approved as a treatment for moderate to severe plaque psoriasis and active psoriatic arthritis.

IL-23 inhibitors have surged in popularity recently, given their ability to treat diseases such as plaque psoriasis.

Janssen’s Stelara (ustekinumab), which inhibits both IL-12 and IL-23, has racked up the most indications. It is now FDA-approved for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Stelara was first FDA-approved in 2009.

Skyrizi is a newer drug, winning FDA approval for plaque psoriasis in 2019.

A 2019 analysis found that Skyrizi had higher efficacy than placebo and Stelara in treating moderate-to-severe chronic plaque psoriasis.

[Image courtesy of AbbVie]

AbbVie won the most recent indication for the drug by providing data from three clinical trials focused on moderately to severely active Crohn’s disease known as ADVANCE, MOTIVATE and FORTIFY1-4.

In the studies, Skyrizi showed significant improvements in endoscopic response compared to placebo as both an induction and maintenance therapy.

“We are proud to offer the first new treatment option in six years for moderately to severely active CD, which may provide patients with a meaningful level of endoscopic improvement,” said Dr. Thomas Hudson, senior vice president, research and development, chief scientific officer, AbbVie, in a press release. “With more than 30 ongoing or planned trials in inflammatory bowel disease, AbbVie is committed to advancing the standards of care for patients by exploring and investing in research for those living with immune-mediated, gastroenterological conditions.”

AbbVie partnered with Boehringer Ingelheim in developing Skyrizi, which was initially known as BI 655066. In 2016, the companies announced they were developing the drug for psoriasis while testing its potential in Crohn’s disease, psoriatic arthritis and asthma.

AbbVie paid an upfront payment of $595 million for the drug plus additional milestone payments and sales royalties.