FDA Extends Review Period for AbbVie’s Skyrizi (risankizumab) sBLA for Moderate to Severe Crohn’s Disease by Three Months

News on March 1, 2022 /BioValleyBIOON/ -- AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has extended the review period for a supplemental Biologics License Application (sBLA) for Skyrizi (risankizumab, 150mg), a novel anti-inflammatory IL-23 inhibitor. The sBLA seeks approval for Skyrizi to treat patients aged ≥16 with moderate to severe Crohn's disease (CD).

FDAThe target date for the sBLA under the Prescription Drug User Fee Act (PDUFA) has been extended by 3 months to review additional data submitted by AbbVie, including information onOn-body InjectorThe information. The currently approved indications for Skyrizi are not affected by this review delay.

Currently, the new indication application for Skyrizi in the treatment of Crohn's disease (CD) is also under review by the European Medicines Agency (EMA), specifically: the use of Skyrizi 600mg intravenous (IV) induction and 360mg (subcutaneous) maintenance regimen for the treatment of moderate to severe active Crohn's disease (CD) patients (aged ≥16 years) who have had an inadequate response, lost response, or are intolerant to conventional or biologic therapies.

New Indication Application for CD Supported by Three Pivotal Phase 3 Clinical Trials (ADVANCE, MOTIVATE, FORTIFY). In the Phase 3 ADVANCE and MOTIVE induction studies, a significantly higher proportion of patients receiving 600mg Skyrizi IV induction therapy achieved the two primary endpoints (clinical remission at week 12 and endoscopic response) compared to placebo.

Phase 3 FORTIFY Maintenance Study Conducted in Patients Who Responded to Skyrizi IV Induction Therapy. Data Showed that, Compared to Patients Who Discontinued Skyrizi, a Significantly Higher Proportion of Patients Receiving Skyrizi 360mg SC Maintenance Therapy Achieved Endoscopic Response and Clinical Remission After One Year (52 Weeks) of Treatment. Across the Three Studies, the Safety Profile of Skyrizi Was Consistent with Its Known Safety Profile, with No New Safety Risks Observed.

Crohn's disease (CD) is a chronic systemic disease characterized by inflammation within the gastrointestinal tract (or digestive tract), causing persistent diarrhea, abdominal pain, and rectal bleeding. It is a progressive disease, meaning that the condition worsens over time. Because the signs and symptoms of CD are unpredictable, it imposes a tremendous burden on patients not only physically but also emotionally and financially.

The active pharmaceutical ingredient of Skyrizi is risankizumab, a monoclonal antibody drug that works bySpecifically targeting the IL-23p19 subunit selectively blocks the immune-inflammatory mediator interleukin-23 (IL-23) in vivo,IL-23 is a cytokine that is considered to play a key role in many chronic immune diseases. Risankizumab was initially developed by German pharmaceutical company Boehringer Ingelheim (BI), and AbbVie acquired the global commercialization rights to risankizumab in February 2016 by paying an upfront fee of $600 million.

Currently, the phase 3 trials for Skyrizi in treating psoriasis, Crohn's disease, and psoriatic arthritisClinical TrialOngoing. Skyrizi is entering a very crowded market and will compete with several drugs, including:NovartisCosentyx and Ilaris,Eli LillyTaltz from AbbVie, Siliq from Valeant, Tremfya from Johnson & Johnson, Ilumya from Sun Pharmaceutical, etc. Among these drugs, Tremfya and Ilumya are also biologic therapies that selectively target IL-23.

However, despite all these competitors,Skyrizi's sales performance was very strong, with global sales reaching $2.939 billion in 2021, representing an increase of 84.9% over the previous year.With a series of Phase 3Clinical TrialThe success of AbbVie has led to an optimistic forecast,Skyrizi and another oral anti-inflammatory drug, the JAK inhibitor Rinvoq, will reach $150 billion in sales by 2025., which will be able to offset the impact on the flagship product Humira (adalimumab) in the U.S. market starting from 2023.BiosimilarSales loss due to competition. (Bioon.com)

Source of the original text:AbbVie Provides Update Regarding SKYRIZI (risankizumab-rzaa) for the Treatment of Moderate to Severe Crohn's Disease in the U.S.