NORTH CHICAGO, Ill., June 23, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) will review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). The application seeks to update the IMBRUVICA U.S. Prescribing Information based on analysis of more than five years of data from the Phase 3 iNNOVATE clinical trial.
NORTH CHICAGO, Ill., June 22, 2020 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA) to expand the BOTOX® prescribing information for the treatment of signs and symptoms of detrusor (bladder muscle) overactivity associated with an underlying neurologic condition (e.g., spina bifida, spinal cord injuries) in pediatric patients (5 -17 years of age) who have an inadequate response to, or are intolerant of, or for any reason unwilling to continue anticholinergic medication.
NORTH CHICAGO, Ill., June 18, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced upadacitinib (15 mg and 30 mg, once daily) monotherapy met the co-primary endpoints of at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) of clear or almost clear (0/1) at week 16 in adults and adolescents with moderate to severe atopic dermatitis who are candidates for systemic therapy.1 Measure Up 1 is the first pivotal Phase 3 study to evaluate the efficacy and safety of RINVOQ for the treatment of moderate to severe atopic dermatitis.
NORTH CHICAGO, Ill., June 17, 2020 /PRNewswire/ -- The board of directors of AbbVie Inc. (NYSE: ABBV) today declared a quarterly cash dividend of $1.18 per share.
IRVINE, Calif., June 15, 2020 /PRNewswire/ -- Today Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the FDA approval of JUVÉDERM® VOLUMA™ XC for the augmentation of the chin region to improve the chin profile in adults over the age of 21.1 As the category leader, the JUVÉDERM® Collection of Fillers has the broadest portfolio of specifically tailored treatment options, and this latest approval marks their fifth approved indication in the U.S.1-5
NORTH CHICAGO, Ill., June 15, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it has 27 studies accepted to the virtual 2020 Annual Scientific Meeting of the American Headache Society (AHS). These abstracts highlight the company's ongoing innovation in migraine, including its investigational product, atogepant, while reinforcing the efficacy and safety profiles of BOTOX® and UBRELVY™.
NORTH CHICAGO, Ill., June 13, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the positive results from the VIALE-A (M15-656) trial, which demonstrated that previously-untreated patients with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy treated with venetoclax (VENCLEXTA® or VENCLYXTO®) plus azacitidine achieved a 34 percent reduction in the risk of death compared to azacitidine in combination with placebo (Hazard Ratio [HR]=0.66 [95 percent CI 0.52-.85], p=0.001).1 Patients receiving the venetoclax combination achieved improved median overall survival (OS) (14.7 months versus 9.6 months in the placebo arm), and 66.4 percent of patients treated with venetoclax plus azacitidine had a composite complete remission (CR + CRi) compared to 28.3 percent treated with azacitidine plus placebo.
NORTH CHICAGO, Ill., June 12, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) has been notified that TRC Capital Investment Corporation (TRC Capital) has commenced an unsolicited "mini-tender" offer, dated June 1, 2020, to purchase up to 1,500,000 shares of AbbVie common stock at $88.05 per share. The offer price is approximately 4.99 percent below the closing price of the AbbVie common stock on May 29, 2020 ($92.67), the last trading day before the date of the offer. AbbVie is not associated in any way with TRC Capital, its mini-tender offer, or the offer documentation.
NORTH CHICAGO, Ill., June 12, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new late-breaking Phase 3b head-to-head data showing superior rates of skin clearance for SKYRIZI® (risankizumab-rzaa) to COSENTYX® (secukinumab) at week 52.1 Particularly, 66 percent of psoriasis patients receiving SKYRIZI achieved completely clear skin—100 percent clearance in the Psoriasis Area and Severity Index (PASI 100)—versus 40 percent of patients receiving COSENTYX at week 52 (p<0.001).1
NORTH CHICAGO, Ill., June 10, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new data from a Phase 2a study of ABBV-3373, an investigational anti-tumor necrosis factor (TNF) Glucocorticoid Receptor Modulator (GRM) steroid antibody drug conjugate (ADC), in adult patients with moderate to severe rheumatoid arthritis.1 The primary endpoint was the change in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) from baseline to week 12 and two statistical comparisons were pre-specified.1 The first compared ABBV-3373 and mean outcome from historical adalimumab data.1 The second compared ABBV-3373 and combined in-trial and historical adalimumab data.1 Results of the first comparison show a greater difference in the primary endpoint change in DAS28-CRP from baseline to week 12 for ABBV-3373 (-2.65) as compared to a pre-specified historical adalimumab mean (-2.13) (p=0.022).1 Results of the second comparison, based on a Bayesian analysis, predicted with a 90 percent probability that ABBV-3373 was associated with a greater improvement on DAS28-CRP from baseline to week 12 than adalimumab based on in-trial data combined with historical data.1 Additionally, evaluations of serum cortisol levels over 12 weeks indicate that ABBV-3373 showed no systemic glucocorticoid effects.1
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