Associated tags: HD, FDA, Chorea, Neurology, Safety, Huntington's disease, Pharmaceutical industry, Food, Disease, Neurocrine Biosciences, VMAT2, TMC, HSG, Patient, SAN, Teva Pharmaceuticals, NYSE, Biotechnology, Pharmaceutical, Medication
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Pharmaceutical industry Innovative Medicines at Teva.
Key Points:
- Innovative Medicines at Teva.
- “AUSTEDO, backed by the longest efficacy and tolerability data to date, has continued to evolve – having received approval for AUSTEDO XR, our once-daily extended-release formulation in February 2023.
- Savings on out-of-pocket costs may vary depending on the patient’s insurance provider and eligibility for participation in the co-pay assistance program.
- For more information regarding cost and coverage options for AUSTEDO XR through Teva Shared Solutions, visit MySharedSolutions.com .
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Pharmaceutical industry SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or have difficulty swallowing.
Key Points:
- SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or have difficulty swallowing.
- "We developed INGREZZA SPRINKLE to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
- "We are pleased to offer the proven efficacy of INGREZZA in reducing uncontrollable movements in a new formulation."
- ‡,†
The U.S. Food and Drug Administration (FDA) approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of INGREZZA SPRINKLE compared to INGREZZA capsules.
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Chorea Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced final results from the HD cohort of the Phase 4 START study, demonstrating positive real-world effectiveness, safety, adherence and satisfaction with the 4-week Titration Kit for AUSTEDO.
Key Points:
- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced final results from the HD cohort of the Phase 4 START study, demonstrating positive real-world effectiveness, safety, adherence and satisfaction with the 4-week Titration Kit for AUSTEDO.
- As a fatal, neurodegenerative disease, HD can cause cognitive deterioration, behavioral and/or psychological problems and uncontrollable body movements known as chorea – a symptom that can have a significant impact on daily activities like eating or talking.3-5 These data are being presented at the 2024 American Academy of Neurology (AAN) Annual Meeting.
- “90% of HD patients experience chorea,3,4 so it’s important for patients to have a treatment option that not only helps address symptoms, but helps provide a positive patient experience,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.
- “I’m glad to see this outcome as it gives clinicians more confidence and patients more control.”
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Thursday, November 2, 2023
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Pharmaceutical industry Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new HD data will be presented at the Huntington Study Group® (HSG) Annual Meeting on November 2-4 in Phoenix, AZ.
Key Points:
- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new HD data will be presented at the Huntington Study Group® (HSG) Annual Meeting on November 2-4 in Phoenix, AZ.
- TMC scores mostly improved with AUSTEDO treatment, and the safety profile was consistent with AUSTEDO’s known safety profile.
- NNTs for treatment success based on CGIC and PGIC ranged from 3-4 and 4-5, respectively, for the VMAT2 inhibitors.
- Significant NNHs included:
Together, the data provide additional insight into the real-world efficacy and safety of AUSTEDO for patients with HD chorea.
Retrieved on:
Thursday, November 2, 2023
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Chorea Interim data suggest one-capsule, once-daily INGREZZA improved chorea at the first evaluation at Week 2 with sustained efficacy through Week 50.
Key Points:
- Interim data suggest one-capsule, once-daily INGREZZA improved chorea at the first evaluation at Week 2 with sustained efficacy through Week 50.
- These data will be presented at the 30th Annual Meeting of the Huntington Study Group on November 2–4 in Phoenix.
- "These interim data provide insight on the clinically meaningful and sustained improvements participants are experiencing with INGREZZA for the treatment of chorea," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences®.
- Additional HD chorea presentations at the 30th Annual Meeting of the HSG include:
The full abstracts can be accessed on the Journal of Huntington's Disease website.
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HD SAN DIEGO, Aug. 28, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new data on now FDA-approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD), including exploratory results from the Phase 3 KINECT®-HD study, which showed consistently greater improvements in HD chorea with INGREZZA versus placebo from Week 2 to Week 12. These data will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders®August 27-31 in Copenhagen, Denmark.
Key Points:
- These data will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders®August 27-31 in Copenhagen, Denmark.
- "The exploratory analysis from our KINECT-HD study further exemplifies the value of INGREZZA as a now approved medication for HD chorea with improvements seen with treatment as early as two weeks," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
- "This exploratory analysis has increased our insight regarding the early and sustained improvements in chorea severity."
- Additional HD chorea presentations at the MDS International Congress of Parkinson's Disease and Movement Disorders include:
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Neurology "We are thankful for those in the HD community who helped contribute to this important milestone, and we remain committed to bringing medicines to patients with unmet medical needs for debilitating neurological disorders."
Key Points:
- "We are thankful for those in the HD community who helped contribute to this important milestone, and we remain committed to bringing medicines to patients with unmet medical needs for debilitating neurological disorders."
- In clinical studies in Huntington's disease, treatment-emergent adverse events included somnolence and sedation, urticaria, rash and insomnia.
- "Data also demonstrated INGREZZA was generally well tolerated and showed clinically meaningful improvement in adults with chorea associated with HD."
- "The approval of INGREZZA for HD chorea means that people living with HD have a new treatment option to help manage their chorea symptoms, which is a welcomed milestone in efforts to improve care for families affected by HD."
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Valbenazine SAN DIEGO, May 19, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that the complete study results from its Phase 3 KINECT™-HD study investigating valbenazine for the treatment of chorea associated with Huntington's disease (HD) has been published in The Lancet Neurology online edition and will appear in the June 2023 print issue. The study met pre-defined primary and secondary endpoints of improvement in chorea severity and global impression of change, demonstrating a reduction in chorea symptoms associated with HD and improvement of overall chorea severity as noticed by clinicians and patients, with improvement seen as early as Week 2 of the initial dose in the 12-week study.
Key Points:
- "The KINECT-HD study data demonstrated statistically significant improvement in chorea associated with HD as compared with placebo.
- The safety profile for participants with chorea associated with HD was consistent with the known safety profile of valbenazine.
- The KINECT-HD study marked the first-ever implementation of the Huntington's Disease Health Index (HD-HI) in a Phase 3 trial.
- The filing included data from the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 open-label study of valbenazine in adults with chorea associated with HD.
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Caregiver AUSTEDO XR was recently approved by the U.S. Food and Drug Administration (FDA) for adults living with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).
Key Points:
- AUSTEDO XR was recently approved by the U.S. Food and Drug Administration (FDA) for adults living with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).
- “The twice-daily formulation will also remain available so that patients may have a choice for what works best for them.
- Once-daily AUSTEDO XR has been shown to be therapeutically equivalent to the twice-daily formulation – offering a new and effective treatment choice.1 AUSTEDO XR may also result in a decreased pill count for patients compared to the twice-daily AUSTEDO.
- For more information regarding cost and coverage options for AUSTEDO XR through Teva Shared Solutions, visit MySharedSolutions.com .
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Migraine Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced six poster abstracts across its neurology portfolio will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 22-27, 2023.
Key Points:
- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced six poster abstracts across its neurology portfolio will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 22-27, 2023.
- Abstracts include data for AUSTEDO (deutetrabenazine) tablets, as well as once-daily AUSTEDO XR (deutetrabenazine) extended-release tablets.
- Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.
- Teva will also present real-world data showing people living with HD chorea who are taking antipsychotic medications with twice-daily AUSTEDO experienced improved motor signs.
