ABBVIE INC. - ABBV STOCK NEWS

AbbVie announced the presentation of 23 abstracts at the 31st European Academy of Dermatology and Venereology Congress, focusing on SKYRIZI® (risankizumab) for treating moderate to severe psoriasis and active psoriatic arthritis. Key presentations include long-term efficacy and safety data from ongoing clinical trials and real-world studies. The research highlights AbbVie's commitment to understanding immune-mediated skin diseases, showcasing innovative treatment options in areas with limited alternatives.

The FDA has approved IMBRUVICA (ibrutinib) for pediatric patients aged one year and older suffering from chronic graft-versus-host disease (cGVHD) after failure of earlier systemic therapies. This marks AbbVie's first pediatric indication for IMBRUVICA and provides a novel treatment for children under 12 affected by cGVHD, a condition following stem cell transplants. The approval is based on positive results from the iMAGINE Phase 1/2 trial, showing a 60% overall response rate in participants. The recommended dosage varies by age, with an oral suspension formulation available for easier administration.

Allergan Aesthetics, part of AbbVie (NYSE: ABBV), has launched a promotion offering double Allē points for consumers who receive treatments with JUVÉDERM^® fillers. This initiative runs until September 30, 2022, and allows users to earn points redeemable for future treatments. The JUVÉDERM^® Collection is the leading dermal filler brand in the U.S., targeting signs of aging with immediate, natural-looking results. The market potential is significant, with an estimated 20 million U.S. consumers interested in filler treatments in the next two years.

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), has received U.S. FDA approval for JUVÉDERM® VOLUX™ XC, the first hyaluronic acid filler designed specifically to enhance jawline definition in adults over 21. This innovation marks the sixth product in the JUVÉDERM® portfolio, which includes renowned fillers like JUVÉDERM® VOLUMA® XC. Clinical studies show that 69.9% of participants experienced significant improvement in jawline definition after six months, with high satisfaction rates. JUVÉDERM® VOLUX™ XC will be available to consumers in early 2023, following comprehensive training for healthcare providers.

AbbVie reported a strong second quarter ending June 30, 2022, with a diluted EPS of $0.51 (up 21.4%) and an adjusted diluted EPS of $3.37 (up 11.2%). Net revenues hit $14.583 billion, a 4.5% increase, bolstered by a 17.8% rise in immunology portfolio revenues. Key products like Skyrizi and Rinvoq saw substantial growth, contributing to expectations of $7.5 billion in combined annual sales. The company confirmed its 2022 adjusted EPS guidance of $13.78-$13.98.

AbbVie announced that the European Commission has approved RINVOQ® (upadacitinib 15 mg, once daily) as the first JAK inhibitor for treating active non-radiographic axial spondyloarthritis (nr-axSpA) in the EU. This approval is based on the Phase 3 SELECT-AXIS 2 trial, where RINVOQ showed significant disease control with nearly half of patients achieving ASAS40 response at week 14. RINVOQ is also approved for ankylosing spondylitis and has received a label enhancement for patients inadequately responding to biologic therapies.

AbbVie (NYSE: ABBV) announced the submission of applications to the U.S. FDA and European Medicines Agency for upadacitinib (RINVOQ®) to treat adults with moderately to severely active Crohn's disease. This follows successful results from three Phase 3 clinical trials showing significant improvements in clinical remission and endoscopic response. The safety profile of upadacitinib remained stable with no new risks identified. These developments reflect AbbVie's commitment to innovation in treating inflammatory bowel disease.

The European Commission has approved RINVOQ (upadacitinib) for adults with moderately to severely active ulcerative colitis, marking its fifth indication in the EU. This decision is supported by three Phase 3 studies demonstrating significant clinical remission, response, and mucosal healing at weeks 8 and 52. Specifically, 26-33% of patients achieved clinical remission at week 8 during induction, and 42-52% at week 52 during maintenance, compared to 4-12% for placebo. Safety results were consistent with prior data, with no new significant risks identified.

AbbVie and Allergan Aesthetics will present over 30 abstracts at the TOXINS 2022 Conference from July 27-30 in New Orleans. Key topics include clinical studies on onabotulinumtoxinA (BOTOX) for chronic migraine, cervical dystonia, and aesthetic applications. Noteworthy presentations include findings from the CD-PROBE study analyzing onabotulinumtoxinA's safety and efficacy in cervical dystonia. AbbVie emphasizes its ongoing commitment to neurotoxin research and enhancing patient outcomes through medical education, showcasing advancements in both therapeutic and aesthetic domains.