Monday, July 12, 2021

AbbVie, building out its post-Humira future, posts 5 late-stage trial wins for Skyrizi and Rinvoq

As AbbVie comes under renewed scrutiny for its pricing and patenting strategies, the company is still working to build out the case for its next-gen immunology drugs Skyrizi and Rinvoq.

In Crohn’s disease, Skyrizi beat placebo in two separate phase 3 studies examining different dosages in adults with moderate to severe disease who have had various prior treatments. The trials met their co-primary endpoints of clinical remission and endoscopic response after 12 weeks. 

Even with those results in hand, AbbVie said it’s waiting on further studies examining the long-term use of Skyrizi in Crohn’s. Once those trials are completed, the company could file for regulatory approval shortly thereafter. 

RELATED: AbbVie’s post-Humira life looks brighter with Skyrizi psoriatic arthritis win

Skyrizi isn’t the only AbbVie drug in the spotlight. The medical journal The Lancet recently published the results from three phase 3 trials—known as Measure Up 1, Measure Up 2 and AD Up—studying the JAK inhibitor Rinvoq in patients with moderate to severe atopic dermatitis. 

In two of those studies, Rinvoq overwhelmingly beat placebo when it came to alleviating itch and skin clearance at both 15 mg and 30 mg doses after 16 weeks, meeting all primary and secondary endpoints. 

In the third AD Up study, Rinvoq also beat placebo at both doses when paired with topical corticosteroids. Specifically, 77% of patients receiving the higher dose had at least a 75% improvement in skin conditions compared with just 26% receiving placebo and topical corticosteroids. That figure was 65% for those on the lower dose. 

AbbVie has high hopes for the newly launched medicines and is hoping they can hit their stride right as megablockbuster Humira faces off against U.S. biosimilars in 2023.

Rinvoq, approved initially in rheumatoid arthritis, is up for FDA consideration in atopic dermatitis, ankylosing spondylitis and psoriatic arthritis. But the FDA recently delayed reviews of the drug in atopic dermatitis and psoriatic arthritis as safety concerns hang over the JAK class.

Meanwhile, Skyrizi is in late-stage testing for Crohn’s disease, psoriatic arthritis and ulcerative colitis. That drug won its initial approval in psoriasis.

Confident in both drugs’ potential, AbbVie management has maintained a forecast of $15 billion in 2025 sales for the pair.

RELATED: AbbVie repeatedly hiked Humira, Imbruvica prices and abused patents to keep competitors at bay: report

However, the positive clinical readouts come at a contentious time for AbbVie. Last week, Congressional lawmakers accused the drugmaker of repeatedly raising its prices and exploited the U.S. patent system on two of its heavyweight drugs, Humira and Imbruvica. 

CEO Richard Gonzalez has defended the company against those accusations, arguing that the drugmaker’s behavior has been “absolutely pro-competitive.” He argued settlements AbbVie reached with other companies will allow Humira generics to enter the market in 2023, roughly a decade before its last patent is set to expire.

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