AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.
The adoption of Continuous Manufacturing (CM) for Oral Solid Dosages (OSD) is often challenged by the limited sensitivity of traditional Process Analytical Technology (PAT), such as Near-infrared (NIR) and Raman spectroscopy, to provide sufficient accuracy for process monitoring and control of low-dose or fixed-dose formulations. This manuscript explores solutions by highlighting advanced control strategies and alternative manufacturing technologies. These strategies include enhanced spectroscopic methods (e.g., Spatially resolved-NIRS, Light-induced fluorescence) to provide improved accuracy/precision, the use of process data and process models (Residence Time Distribution, Multivariate Statistical Process Control) as soft sensors, hybrid PAT and process models and more traditional at-line/off-line monitoring using NIR, Raman or high-sensitivity liquid chromatography with stratified sampling and bracketing. Alternatively, several technologies inherently ensure high content uniformity, such as semi-Continuous Manufacturing (sCM) with accurate mini-batch dispensing and Dry Coating Technology. For Twin-Screw Hot Melt Extrusion (HME) molecular-level mixing delivers more uniform blends, but current low-dose applications still require pre-blending of the drug substance with suitable excipients. When fed with a uniform powder blend, twin screw wet granulation also ensures compliant content uniformity without the need for PAT monitoring. In conclusion, a successful CM of low dose products may be possible when strategically combining advanced spectral and data approaches, modelling, and innovative platforms to build robust and validated process controls. This has been demonstrated across multiple peer reviewed studies and is now gradually being incorporated into control strategies for the commercial manufacture of pharmaceutical products.
Foslevodopa/foscarbidopa (LDp/CDp) is a nonsurgical 24-h continuous subcutaneous infusion for patients with advanced Parkinson’s disease (aPD) and motor fluctuations uncontrolled on oral medications. We present the first multicountry real-world data from routine clinical practice. ROSSINI (NCT06107426) is an ongoing 3-year multicountry, prospective, observational study of adults with aPD who are LDp/CDp-naïve (cohort A) or transitioning from LDp/CDp open-label extension studies (NCT04379050/NCT04750226, cohort B). For this interim analysis, the primary endpoint was change from baseline to 6 months in OFF time [Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part IV (MDS-UPDRS-IV) modified item 4.3]. Safety was assessed by monitoring adverse events (AEs). Interim results for 105 cohort A patients enrolled ≥ 6 months by March 24, 2025 are presented only; cohort B results were limited (n = 5). Mixed-effects models for repeated measurements (continuous outcomes) were utilized, adjusted for country. Cohort A patients had a mean (SD) age of 68.5 (9.5) years, PD duration of 12.1 (5.3) years, and least squares mean (SE) OFF time of 5.2 (0.6) h at baseline. Patients on LDp/CDp showed statistically significant reductions (95
Previous reports have suggested concurrence of cervical dystonia (CD) and chronic migraine (CM); however, the extent of the burden is unclear. This analysis estimated the prevalence of comorbid CD and CM (CD + CM) and described patient characteristics and health care costs among real-world patients with CD + CM. This retrospective cohort study used administrative claims data from the Merative MarketScan (January 1, 2017–December 31, 2021) and Optum® Market Clarity databases (January 1, 2017–September 30, 2021). Adults with CD and/or CM were identified using ICD-10-CM diagnosis codes. Outcomes were summarized descriptively and included prevalence of CD, CM, and CD + CM; relative risk of comorbid CD + CM; patient characteristics stratified by cohort and botulinum neurotoxin (BoNT) exposure status; and health care costs for CD + CM. In 2017–2021, numbers of patients identified as above annually ranged from 10.5 million to 16.3 million. The relative risk of CM among patients with CD, and of CD among patients with CM, was 31.8 and 39.5, respectively. Among patients with CD, the overall prevalence of CD + CM from 2017 to 2021 was 12.6
Risankizumab (RZB) and deucravacitinib (DEU) are both approved for the treatment of moderate-to-severe psoriasis. Physicians value head-to-head comparisons between available therapies to make evidence-based treatment decisions. This study evaluates the safety and efficacy of RZB compared with DEU for the treatment of patients with moderate psoriasis who have not previously received biologic treatment. Patients with moderate psoriasis, eligible for systemic treatment and without prior biologic exposure, were enrolled in a 1:2 ratio to RZB or DEU, respectively. The 52-week treatment was divided into two periods: period A (baseline to week 16) and period B (weeks 16–52). Results from period A are presented here. In period A, patients either received a single subcutaneous injection of RZB 150 mg on day 1 and week 4 or oral DEU 6 mg daily. The coprimary endpoints in period A were achievement of ≥ 90
Treatment for exocrine pancreatic insufficiency (EPI) includes pancreatic enzyme replacement therapy (PERT). Although PERT may improve symptoms, there are currently no EPI symptom measures to monitor PERT treatment. This analysis evaluated the utility of the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) in patients with chronic pancreatitis and EPI treated with pancrelipase. This prospective, observational study (NCT04949828) included adult patients with chronic pancreatitis and EPI who were recommended pancrelipase 72,000 lipase units per meal and 36,000 lipase units per snack by an independent physician. Outcomes included the change from baseline to 1 month and 3 months after treatment initiation in PEI-Q symptom score, PEI-Q symptom severity categories, and health-related quality of life (HRQoL) as measured by the PEI-Q impact domain score. The per-protocol population included 32 and 29 patients with data at 1 and 3 months after pancrelipase initiation, respectively. A significant reduction in mean PEI-Q symptom scores was observed from baseline to 1 month (− 1.0; p < 0.001) and 3 months (− 1.1; p < 0.001). Despite all patients having moderate/severe EPI symptoms at baseline, 62.5
