AbbVie Inc. reports pharmaceutical developments across immunology, neuroscience, oncology and Allergan Aesthetics. Recurring updates include financial results by product portfolio, clinical and real-world data for therapies such as SKYRIZI and RINVOQ, FDA regulatory submissions and response letters, and medical-conference presentations in inflammatory bowel disease and other immune-mediated conditions.
Company news also covers pipeline spending, acquired in-process research and development, manufacturing capacity for medicines in core therapeutic areas, and investor conference appearances. AbbVie’s product references commonly include SKYRIZI, RINVOQ, Botox Therapeutic, Vraylar, Ubrelvy, Qulipta, Venclexta, Imbruvica and Elahere.
AbbVie (NYSE: ABBV) will release its first-quarter 2022 financial results on April 29, 2022, before the market opens. A live webcast of the earnings conference call will take place at 8 a.m. CT, accessible via AbbVie's Investor Relations website. An archived edition will be available later that day. AbbVie aims to address serious health issues through innovative medicines across various therapeutic areas, including immunology, oncology, and virology. For more details, visit abbvie.com.
AbbVie and Genmab announced topline results from the EPCORE™ NHL-1 clinical trial for epcoritamab (DuoBody®-CD3xCD20), targeting relapsed/refractory large B-cell lymphoma (LBCL). The trial involved 157 patients with a confirmed overall response rate (ORR) of 63.1% and a median duration of response (DOR) of 12 months. Common adverse events included cytokine release syndrome (49.7%) and neutropenia (21.7%). The companies plan to engage global regulatory authorities and present data at a future medical conference.
Genmab (NASDAQ: GMAB) and AbbVie (NYSE: ABBV) announced positive topline results from the EPCORE™ NHL-1 clinical trial for epcoritamab, a bispecific antibody targeting large B-cell lymphoma (LBCL). The trial, involving 157 patients, demonstrated an overall response rate (ORR) of 63.1%, surpassing efficacy benchmarks, with a median duration of response (DOR) of 12 months. The companies will engage global regulatory authorities to determine next steps and plan to present detailed data at an upcoming medical meeting.
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AbbVie has announced promising results from a Phase 2 trial of navitoclax combined with ruxolitinib for myelofibrosis, a challenging blood cancer. The exploratory analysis included 34 patients, with a 100% survival estimate for those showing grade improvement in bone marrow fibrosis after over two years. Importantly, 38% of patients had a significant improvement in fibrosis, while 23% showed a reduction in variant allele frequency. Presented at AACR 2022, these findings support ongoing Phase 3 studies and suggest navitoclax may enhance patient outcomes in myelofibrosis.
AbbVie announced positive results from the Phase 3 VIRGO trial, evaluating the investigational twice-daily administration of VUITY, an eye drop for presbyopia. The study demonstrated significant improvement in near vision without compromising distance vision. A total of 230 participants were involved, with results indicating that participants gained three lines or more in near visual acuity at Day 14. These findings will support a supplemental New Drug Application to the FDA in Q2 2022. While VUITY is FDA-approved for once-daily use, twice-daily administration is not yet approved.
Allergan Aesthetics, part of AbbVie (NYSE: ABBV), has entered a groundbreaking partnership with Resorts World Las Vegas to become the preferred aesthetics and rewards partner at the resort. This multiyear agreement grants Allergan exclusive branding rights to the Allē Lounge on 66 and the Allē Backstage space at the Resorts World Theatre. The partnership aims to enhance consumer engagement and introduce millions of visitors to Allergan’s product portfolio. This marks Allergan's first branding of a dedicated area at a major resort.
AbbVie (NYSE: ABBV) will present 30 abstracts at the 2022 American Academy of Neurology Annual Meeting, showcasing its leadership in neuroscience. Key highlights include ongoing research on migraine treatments, particularly the newest migraine medicine, atogepant (QULIPTA™), and advancements in therapies for advanced Parkinson's disease. Notable studies will also focus on spasticity and cervical dystonia with data on onabotulinumtoxinA (BOTOX®). The meeting will take place in Seattle from April 2-7, 2022, with virtual presentations from April 24-26.
AbbVie and Allergan Aesthetics will present 12 abstracts and two late-breaking presentations at the 2022 AAD Annual Meeting, showcasing their commitment to dermatologic research. Key highlights include new findings on RINVOQ® and SKYRIZI® in treating atopic dermatitis and psoriasis. Notably, a post-hoc analysis indicates RINVOQ's superior efficacy compared to DUPIXENT® in moderate to severe atopic dermatitis. Allergan will introduce a novel hydrating serum and present data on HA injectable gel for jawline definition. These presentations emphasize the companies' dedication to enhancing patient care in dermatology.
AbbVie announced that the FDA approved RINVOQ (upadacitinib) for treating adults with moderately to severely active ulcerative colitis (UC) who have not adequately responded to TNF blockers. This indicates AbbVie's expansion into gastroenterology with RINVOQ now approved for four indications. In clinical trials, RINVOQ showed higher rates of clinical remission and response, achieving significant outcomes at weeks 8 and 52 compared to placebo. The treatment may cause serious side effects, including infections and cardiovascular risks, warranting careful patient monitoring.