AbbVie has tacked down its first regulatory approval for risankizumab as it begins what it hopes is a global rollout for the psoriasis drug in 2019 with a plan to quickly attain megablockbuster status.
Japan became the first country to stamp an OK on the drug, which has been dubbed Skyrizi for the marketing campaign. Evaluate has tagged this IL-23 drug as the number 3 blockbuster on its list of heavyweight drugs looking at a 2019 launch. They believe this drug could earn more than $2 billion in 2024.
That’s peanuts compared to the $4 billion to $5 billion revenue estimates offered by the AbbVie team, who are anxious to have a successor to Humira as it winds down to the US patent cliff, likely in 2023.
AbbVie paid Boehringer $595 million upfront to license rights to risankizumab in early 2016. In a Phase III double header reported in the fall of 2017, researchers pitted the drug against Stelara (ustekinumab) and Humira (adalimumab). Their top prospect came through on all scores, outpacing the other two in clearing psoriasis while the placebo arm comparison numbers barely budged. It’s a hyper competitive field, though, with a number of new drugs carving up the marketplace.
Global Data highlighted the “important” first step, but notes that this approval will do little in terms of hitting that blockbuster goal. Their analysts estimate 2027 revenue in Japan at $28 million.
The big money awaits in the US and then Europe, where regulators are now pondering AbbVie’s applications. Japan’s approval is an indication of good odds on both sides of the Atlantic.
Barclays, meanwhile, looked over the hyper competitive landscape and raised questions about the drug’s potential.
AbbVie’s Humira continues to dominate despite the introduction of newer biologics including: JNJ’s anti-IL23 Tremfya, JNJ’s anti-IL12/23 Stelara, and Lilly’s anti-IL-17 Taltz (see Figure 1 and 2)—with its own anti-IL23 mirikizumab in phase 3 development for both psoriasis and ulcerative colitis. Moreover, despite being positioned as a best-in-class option, risankizumab failed in a proof-of-concept ankylosing spondylitis study, raising additional questions over its profile as AbbVie expands late-stage development into Crohn’s disease, ulcerative colitis, psoriatic arthritis, and asthma.
The PDUFA date should be on or close to April 25th.
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