- The Food and Drug Administration has approved Skyrizi for plaque psoriasis, the first U.S. approval for an immunology therapy which AbbVie hopes will help lead the big biotech into a post-Humira future.
- Skyrizi's annual list price for maintenance dosing will be $59,000 with a commercial launch set for early May, AbbVie said in a statement to BioPharma Dive. The IL-23 inhibitor will face stiff competition from rival therapies marketed by Johnson & Johnson, Novartis and Eli Lilly.
- Yet AbbVie expects Skyrizi's sales to grow to $5 billion by 2023, according to a 2017 company presentation. That growth would be driven by multiple label expansions in the next few years as more clinical results roll in for psoriatic arthritis, Crohn's disease and ulcerative colitis. An AbbVie spokesperson pointed to the company's earnings call Thursday for additional details on the 2023 estimate.
The psoriasis approval for Skyrizi (risankizumab) in the U.S. was expected, following a similar go-ahead from regulators in Japan and a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use.
In Phase 3 studies of the drug, roughly 80% of patients with moderate to severe plaque psoriasis achieved 90% clear skin and slightly more than half reached complete skin clearance using Skyrizi.
However, the anti-IL23 antibody is far from alone in the next generation of immunology drugs. Other interleukin inhibitors already on the market include J&J's anti-IL 12/23 Stelara (ustekinumab) as well as the IL-17 inhibitors Cosentyx (secukinumab) and Taltz (ixekizumab), respectively marketed by Novartis and Eli Lilly.
One Novartis executive gave an immediate taste of the competition AbbVie can expect to face, dismissing the new drug on the Swiss pharma's first quarter earnings call only hours after the approval was announced.
"We don't think there is anything clinically to be gained by risankizumab entering the market at all," Novartis Pharmaceuticals CEO Paul Hudson said Wednesday morning, adding "more than skin needs to be treated."
Hudson argued IL-17 drugs, including Novartis' Cosentyx, would be preferred given their effectiveness in nail and scalp treatment in psoriasis.
For its own part, AbbVie has previously emphasized the skin clearance rates compared to these rivaling drugs, as well as a less frequent dosing regimen.
Beyond its external foes, Skyrizi will also face the intriguing challenge of competing internally against the world's best-selling drug, Humira (adalimumab), as both targeting similar diseases.
"The main controversy for AbbVie will be how much and how quickly the company can transition psoriasis patients to Skyrizi from Humira, which is expected to face biosimilar competition in the US starting in 2023 and is already eroding ex-US," SVB Leerink analyst Geoffrey Porges wrote in a note to investors.
In anticipation of Humira's patent cliff, AbbVie's future is based on the realization of a late-stage pipeline that includes Skyrizi along with Imbruvica (ibrutinib), Venclexta (venetoclax), upadacitinib and others.
Skyrizi has not come cheap to AbbVie, which bought the commercial rights in 2016 from Boehringer Ingelheim. In that deal, AbbVie paid $595 million upfront and lined up $1.6 billion in potential milestone payments as well as an undisclosed level of royalties.
A company spokesperson referenced the deal's 2016 release for further information, which does not specify the royalty rates or suggest how much of the milestones have been paid or remain outstanding.
AbbVie's first quarter earnings call is set for 9 a.m. Thursday.