AbbVie NYSE:ABBV Stock Report

AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson's Disease

AbbVie announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). The submission is based on results from a Phase 3, head-to-head, randomized and controlled clinical trial demonstrating statistically significant improvement in "On" time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD). ABBV-951 is designed to provide a first-of-its-kind, 24-hour, continuous subcutaneous delivery of CD/LD. Compared to oral CD/LD, it offers the potential for improvement in motor fluctuations in patients with advanced Parkinson's disease, a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells,1 which primarily manifests with tremor, muscle rigidity, slowness of movement and difficulty with balance. In PD, patients and their healthcare providers share the same goal: to extend the amount of "On" time, referring to the period when symptoms are well controlled without dyskinesia or involuntary movements. The NDA is based primarily on data from the M15-736 study, a Phase 3 randomized, double-blind, double-dummy, active-controlled study, which demonstrated statistically superior efficacy of ABBV-951 compared to oral immediate-release CD/LD in controlling motor fluctuations in advanced PD patients.2 Approximately 130 adult participants with PD, whose motor symptoms were no longer adequately controlled by their current medications, were enrolled in the study across 80 sites in the U.S. and Australia. The majority of adverse events (AEs) were non-serious and mild or moderate in severity in the ABBV-951 group. There was one patient with a treatment-emergent AE leading to death in the oral CD/LD group and none in the ABBV-951 group. The most common AEs reported in = 10% patients in the ABBV-951 group were infusion site AEs (erythema, pain, cellulitis and edema) and dyskinesia. The submission is also supported by results from an ongoing multi-center, Phase 3, 52-week, single arm, open-label study (M15-741), which is assessing the long-term safety and efficacy of ABBV-951. AbbVie will continue to pursue regulatory submissions for ABBV-951 across international markets throughout the year. ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and levodopa prodrugs for continuous subcutaneous delivery that is being investigated for the treatment of motor fluctuations in patients with advanced Parkinson's disease. The Phase 3 randomized, double-blind, double-dummy, active-controlled study compared the efficacy, safety and tolerability of ABBV-951 (foscarbidopa/foslevodopa) to oral immediate-release CD/LD in patients with advanced PD. Participants were provided with a home diary (the PD Diary) to assess their motor state during the day. The primary endpoint of good "On" time (defined as "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia), was collected and averaged over three consecutive days and normalized to a typical 16-hour waking period. Baseline values are defined as the average of normalized good "On" time collected over the three PD Diary days before randomization. Approximately 130 adult participants with advanced PD were enrolled in the study across 80 sites in the U.S. and Australia. Participants were randomized 1:1 to receive either the ABBV-951 solution as a continuous delivery under the skin (subcutaneous) plus oral placebo capsules for carbidopa/levodopa or oral capsules containing immediate-release carbidopa/levodopa plus continuous subcutaneous delivery of placebo solution for ABBV-951. The treatment duration was 12 weeks.

Vice Chairman & President exercised options and sold US$28m worth of stock

On the 10th of May, Michael Severino exercised 300k options at a strike price of around US$54.44 and sold these shares for an average price of US$149 per share. This trade did not impact their existing holding. Since December 2021, Michael's direct individual holding has decreased from 103.25k shares to 64.40k. Company insiders have collectively sold US$75m more than they bought, via options and on-market transactions in the last 12 months.

AbbVie Inc. Achieved Clinical Remission and Endoscopic Response At One Year in Phase 3 Maintenance Study in Patients with Crohn's Disease

AbbVie announced positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to a conventional or biologic therapy. The results showed that more patients treated with either dose of upadacitinib (15 mg or 30 mg once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo. Use of upadacitinib in Crohn's disease has not been evaluated by health authorities. Results from the U-ENDURE maintenance study, in addition to results from the U-EXCEED and U-EXCEL induction studies, will be included in future regulatory submissions. In the U-ENDURE maintenance study, patients from U-EXCEED and U-EXCEL who responded to 12 weeks of upadacitinib 45 mg oral induction treatment were re-randomized to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo. Clinical remission was defined by the Crohn's Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP). A significantly higher proportion of patients who received upadacitinib 15 mg or 30 mg achieved clinical remission per the CDAI at week 52: 37 and 48%, respectively, versus 15% in the placebo group (p<0.0001). Results also showed that 36 and 46% of patients who received upadacitinib 15 mg and 30 mg, respectively, achieved clinical remission at week 52 per SF/AP compared to 14 % in the placebo group (p<0.0001).1 At week 52, 28 and 40% of patients who received upadacitinib 15 mg and 30 mg, respectively, achieved endoscopic response compared to 7 % of patients who received placebo (p<0.0001).1 In addition, 19 and 29 % of patients who received upadacitinib 15 mg and 30 mg achieved endoscopic remission, respectively, compared to 5% of patients in the placebo group (p<0.0001).1 A significantly higher proportion of patients who received upadacitinib 15 mg or 30 mg achieved corticosteroid-free clinical remission per CDAI and per SF/AP compared to placebo at week 52 among patients taking corticosteroids at baseline. The safety results of upadacitinib (15 mg or 30 mg) were generally consistent with the safety profile observed in the Phase 3 induction studies in Crohn's disease, as well as the known safety profile of upadacitinib. No deaths were reported throughout the study and no new safety risks were identified. A total of 673 patients completed the 12-week upadacitinib induction treatment with clinical response and received at least one dose of the study drug in the placebo-controlled maintenance period. The most common adverse events in the upadacitinib groups were exacerbation of Crohn's disease, arthralgia and pyrexia. Serious adverse event and serious infection event rates per 100 patient years were the following for placebo, upadacitinib 15 mg, and upadacitinib 30 mg groups, respectively: 37.4/8.4, 25.0/6.1, 21.0/7.8. Malignancies (excluding non-melanoma skin cancer [NMSC]) reported in the study included one event in the upadacitinib 15 mg group, two events in the upadacitinib 30 mg group and no events in the placebo group.1 No adjudicated thrombotic events were reported in the upadacitinib 15 mg and placebo groups; one adjudicated hepatic vein thrombosis was reported in the upadacitinib 30 mg group.1 No adjudicated major adverse cardiovascular event (MACE) was reported in any treatment group.1 One patient each in the upadacitinib 15 mg, 30 mg and placebo groups experienced an event of adjudicated gastrointestinal perforation. The U-ENDURE Phase 3 study was designed to evaluate the efficacy and safety of upadacitinib as maintenance therapy versus placebo in patients with moderate to severe Crohn's disease who responded to upadacitinib induction treatment in the U-EXCEED or U-EXCEL induction studies. Full results from the U-ENDURE study maintenance period will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of upadacitinib in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

Vincent Wong Commences Class Action Lawsuit on Behalf of Investors Who Purchased Between April 30, 2021 and August 31, 2021