AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson’s Disease
AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson’s Disease
- If approved, ABBV-951 will offer sufferers the primary continuous subcutaneous delivery of carbidopa/levodopa prodrugs
- Submission is supported by way of Phase 3 look at that proven sufferers had tremendous will increase in hours of “On” time without troublesome dyskinesia, in comparison to oral instant-release carbidopa/levodopa
NORTH CHICAGO, Ill., May 20, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) today introduced 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 sufferers with advanced Parkinson’s disease (PD).
The submission is based on outcomes from a Phase 3, head-to-head, randomized and managed clinical trial demonstrating statistically extensive improvement in “On” time with out difficult dyskinesia in comparison to oral immediately-launch carbidopa/levodopa (CD/LD).
ABBV-951 is designed to offer a primary-of-its-kind, 24-hour, non-stop subcutaneous transport of CD/LD. Compared to oral CD/LD, it offers the ability for improvement in motor fluctuations in sufferers with superior Parkinson’s sickness, a progressive and chronic neurological disease due to the lack of dopamine-producing brain cells,1 which basically manifests with tremor, muscle rigidity, slowness of motion and trouble with balance. In PD, sufferers and their healthcare vendors percentage the same intention: to increase the amount of “On” time, referring to the duration whilst signs and symptoms are properly managed without dyskinesia or involuntary moves.
“Advanced Parkinson’s sickness reasons unrelenting demanding situations and uncertainty for sufferers and caregivers international,” stated Thomas Hudson, M.D., senior vice chairman, studies and development, leader clinical officer, AbbVie. “We are committed to addressing the unmet needs of those suffering from the disorder and apprehend the urgency for a new remedy that could enable higher symptom control through the continuous 24-hour administration of medication.”
The NDA is based totally generally on facts from the M15-736 have a look at, a Phase 3 randomized, double-blind, double-dummy, lively-managed observe, which confirmed statistically advanced efficacy of ABBV-951 in comparison to oral immediately-launch CD/LD in controlling motor fluctuations in advanced PD patients.2 Approximately 130 adult contributors with PD, whose motor signs and symptoms had been now not safely managed by means of their present day medications, have been enrolled inside the examine throughout eighty websites inside the U.S. And Australia.
The majority of damaging occasions (AEs) were non-extreme and mild or slight in severity in the ABBV-951 group. There turned into one patient with a remedy-emergent AE main to dying in the oral CD/LD organization and none within the ABBV-951 group. The maximum common AEs stated in ≥ 10% sufferers in the ABBV-951 organization had been infusion web page AEs (erythema, pain, cellulitis and edema) and dyskinesia. The submission is also supported by means of results from an ongoing multi-middle, Phase 3, 52-week, unmarried arm, open-label look at (M15-741), that’s assessing the lengthy-term safety and efficacy of ABBV-951.
AbbVie will maintain to pursue regulatory submissions for ABBV-951 throughout global markets all through the 12 months.
About ABBV-951
ABBV-951 (foscarbidopa/foslevodopa) is an answer of carbidopa and levodopa prodrugs for continuous subcutaneous transport this is being investigated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.
About the Phase three M15-736 Study3
The Phase 3 randomized, double-blind, double-dummy, active-managed observe compared the efficacy, safety and tolerability of ABBV-951 (foscarbidopa/foslevodopa) to oral immediately-launch CD/LD in sufferers with advanced PD. Participants were supplied with a home diary (the PD Diary) to assess their motor kingdom at some point of the day. The number one endpoint of proper “On” time (defined as “On” time with out dyskinesia plus “On” time with non-difficult dyskinesia), became amassed and averaged over 3 consecutive days and normalized to a regular sixteen-hour waking duration. Baseline values are described because the common of normalized proper “On” time accrued over the 3 PD Diary days earlier than randomization. Approximately one hundred thirty adult contributors with superior PD had been enrolled in the look at across 80 websites within the U.S. And Australia. Participants have been randomized 1:1 to receive both the ABBV-951 answer as a continuous shipping beneath the pores and skin (subcutaneous) plus oral placebo drugs for carbidopa/levodopa or oral pills containing on the spot-launch carbidopa/levodopa plus non-stop subcutaneous transport of placebo answer for ABBV-951. The treatment length became 12 weeks. More records on the take a look at may be located on www.Clinicaltrials.Gov (NCT04380142).
About Parkinson’s Disease
More than 10 million people global are residing with Parkinson’s ailment (PD)four, a innovative and continual neurological disorder characterised by way of tremor, muscle tension, slowness of motion, and difficulty with balance.1 The motor symptoms of PD end result from the loss of dopamine-producing mind cells and begin while approximately 60-80 percent of these cells are lost.5 Symptoms retain to get worse slowly over the direction of time.6 While there’s no regarded remedy for the disease, there are treatments available to assist lessen signs.7
As PD progresses, sufferers enjoy motor headaches, which includes motor and non-motor fluctuations and dyskinesia. Patients file switching from an “On” kingdom (while signs are commonly nicely managed) to an “Off” nation, for the duration of which signs and symptoms inclusive of tremor and stiffness might also reappear and patients have extra trouble in transferring.8 Patients with advanced PD may additionally revel in dyskinesia (involuntary movements) which could appreciably prevent every day sports.eight Neuronal degeneration and fluctuating plasma levodopa ranges are accountable for the onset of these motor complications, with 50 percentage of sufferers reporting them to 5 years after diagnosis and approximately 80-one hundred percent of sufferers imparting with them after 10 years.nine
About AbbVie in Neuroscience
At AbbVie, our dedication to keep the personhood of those residing with neurological and psychiatric problems is unwavering. Every challenge in this uncharted territory makes us extra decided and drives us tougher to discover and supply solutions for patients, care partners and clinicians. AbbVie’s Neuroscience portfolio consists of authorised remedies in neurological and psychiatric problems, consisting of bipolar I ailment, primary depressive ailment, migraine, Parkinson’s disease, submit-stroke spasticity, schizophrenia, and others along side a robust pipeline.
We have a sturdy funding in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery web site in Ludwigshafen, Germany, in which our research and resilience in those tough healing areas is yielding a deeper knowledge of the pathophysiology of neurological and psychiatric disorders, and figuring out objectives for capacity disease-enhancing therapeutics aimed at making a distinction in human beings’s lives.
About AbbVie
AbbVie’s challenge is to find out and deliver revolutionary drug treatments that remedy severe fitness problems today and address the medical challenges of the next day. We attempt to have a tremendous impact on humans’s lives across several key healing regions: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, similarly to products and services across its Allergan Aesthetics portfolio. For extra facts about AbbVie, please go to us at www.Abbvie.Com. Follow @AbbVie on Twitter, Facebook, Instagram, YouTube and LinkedIn
Forward-Looking Statements
Some statements on this information launch are, or may be taken into consideration, forward-searching statements for functions of the Private Securities Litigation Reform Act of 1995. The words “trust,” “count on,” “expect,” “project” and similar expressions, among others, typically become aware of forward-searching statements. AbbVie cautions that those forward-looking statements are problem to dangers and uncertainties that could motive real consequences to vary materially from those indicated inside the forward-looking statements. Such risks and uncertainties encompass, however are not confined to, failure to recognize the predicted benefits from AbbVie’s acquisition of Allergan % (“Allergan”), failure to promptly and efficiently integrate Allergan’s organizations, competition from different products, challenges to intellectual property, difficulties inherent within the studies and development technique, unfavourable litigation or government movement, modifications to legal guidelines and regulations relevant to our enterprise and the impact of public fitness outbreaks, epidemics or pandemics, inclusive of COVID-19. Additional data about the economic, aggressive, governmental, technological and other factors which could have an effect on AbbVie’s operations is about forth in Item 1A, “Risk Factors,” of AbbVie’s 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as up to date by way of its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no duty to launch publicly any revisions to forward-searching statements because of subsequent events or developments, except as required by regulation.
References:
1 About Parkinson’s: Parkinson’s one hundred and one. The Michael J. Fox Foundation for Parkinson’s Research. Available at: https://www.Michaeljfox.Org/knowledge-parkinsons/i-have-were given-what.Php#q2. Accessed March 1, 2022.
2 AbbVie. Data on record.
3 Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations in Adult Participants With Advanced Parkinson’s Disease. ClinicalTrials.Gov. 2021. Available at: https://www.Clinicaltrials.Gov/ct2/display/NCT04380142?Time period=NCT04380142&draw=2&rank=1. Accessed March 1, 2022.
4 Statistics. Parkinson’s Foundation. Available at: https://www.Parkinson.Org/Understanding-Parkinsons/Statistics#:~:textual content=More%20thanp.C2010percent20millionp.C20people. Accessed March 1, 2022.
5 Parkinson’s Disease: Hope Through Research. National Institute of Neurological Disorders and Stroke. Available at: https://www.Ninds.Nih.Gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research#:~:textual content=Lossp.C20of%20dopamine%20resultsp.C20in,by way ofpercent20thepercent20timep.C20symptomsp.C20appear. Accessed March 1, 2022.
6 Parkinson’s Disease: Challenges, Progress, and Promise. National Institute of Neurological Disorders and Stroke. Available at: https://www.Ninds.Nih.Gov/Disorders/All-Disorders/Parkinsons-Disease-Challenges-Progress-and-Promise. Accessed March 1, 2022.
7 Parkinson’s Disease. National Institute on Aging. Available at: https://www.Nia.Nih.Gov/fitness/parkinsons-sickness. Accessed March 1, 2022.
eight Wearing off and motor fluctuations. European Parkinson’s Disease Association. Available at: https://www.Epda.Eu.Com/approximately-parkinsons/signs/motor-signs/carrying-off-and-motor-fluctuations/. Accessed March 1, 2022.
nine Freitas ME, Hess CW, Fox SH. Motor Complications of Dopaminergic Medications in Parkinson’s Disease. Semin Neurol. 2017;37(2):147-157. Doi:10.1055/s-0037-1602423).
SOURCE AbbVie
PR Newswire supply:
