AbbVie’s Produodopa® (foslevodopa-foscarbidopa) Accepted by Scottish Medicines Consortium as Treatment Option for Advanced Levodopa-Responsive Parkinson’s Disease

For Medical and Trade media.

• Foslevodopa-foscarbidopa will soon be available for eligible patients with advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia in Scotland, providing an additional option when currently available combinations of treatments have not given satisfactory results¹
• Following the recommendation by the National Institute for Health and Care Excellence (NICE) in November 2023, this means foslevodopa-foscarbidopa will soon be available for use within the NHS across the UK²
• The advice from the Scottish Medicines Consortium (SMC) is supported by data from two Phase 3 clinical trials, one of which demonstrated that foslevodopa-foscarbidopa reduced “Off” time (p=0.0054) and increased “On” time without a troublesome dyskinesia (p=0.0083), compared to oral immediate release levodopa carbidopa.³

MAIDENHEAD, UK, 11^th March 2024 – AbbVie (NYSE: ABBV) today announced that the Scottish Medicines Consortium (SMC) has accepted Produodopa^® (foslevodopa-foscarbidopa) for restricted use within NHS Scotland for the treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson’s medicinal products have not given satisfactory results. The SMC has restricted its use to patients with advanced Parkinson’s disease who are not eligible for deep brain stimulation (DBS). Foslevodopa-foscarbidopa offers an additional treatment choice in the therapeutic class of dopa and dopa derivatives for this indication. Another medicine within this therapeutic class has been accepted via the orphan medicine process for this indication. This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.¹

There are approximately 153,000 people with Parkinson’s disease across the UK and 12,400 of these live in Scotland, with about 30 people diagnosed with this progressive and chronic condition every week^4,5 It is a progressive neurological disorder resulting from the loss of dopamine-producing brain cells and is characterised by tremor, muscle rigidity, slowness of movement and difficulty with balance.4^,6-8 As Parkinson’s disease progresses, the severity of symptoms increases.⁹ Advanced Parkinson’s disease is marked by complex symptoms such as severe motor deficits, risk of falls, and cognitive problems.¹⁰

Foslevodopa-foscarbidopa is a new, soluble formulation of levodopa/carbidopa prodrugs, which can be self-administered by continuous subcutaneous infusion via a pump 24 hours a day.¹¹ It has been developed to provide another therapeutic option for eligible patients with advanced levodopa-responsive Parkinson’s disease.¹¹

“Given the individual nature of Parkinson’s disease and associated symptoms, some treatments may not be suitable for certain patients. As such, providing a choice around therapies for those with advanced or complex stages of the condition is important,” said Dr. Esther Sammler, Consultant Neurologist and Senior Clinical Lecturer at the University of Dundee. “Foslevodopa-foscarbidopa offers an additional treatment option that can be self-administered, or administered with the assistance of a caregiver, when currently available combinations of treatments have failed to provide satisfactory results.”

Parkinson’s disease is frequently talked about in terms of “On” and “Off” time. “On” time refers to when symptoms are controlled, while “Off” time is when Parkinson’s disease symptoms – motor and/or non-motor – return between medication doses or may occur unpredictably.^12,13

The SMC advice is supported by data from two Phase 3 clinical trials, which demonstrated that foslevodopa-foscarbidopa reduced off time (p=0.0054) and increased on time without a troublesome dyskinesia (p=0.0083), compared to oral immediate release levodopa carbidopa and evaluated safety and tolerability. The most frequent adverse reactions (≥10%) reported in all Phase 3 studies in patients exposed to foslevodopa-foscarbidopa were infusion site events (infusion site erythema, infusion site cellulitis, infusion site nodule, infusion site pain, infusion site oedema, infusion site reaction, and infusion site infection), hallucination, fall, and anxiety.¹¹

“The SMC’s decision to make this treatment available on the NHS in Scotland means that eligible patients across the UK will now be able to access this treatment option,” said Rachael Millward, Medical Director, AbbVie UK. “AbbVie is committed to transforming the standards of care in Parkinson’s disease and delivering therapies to support patients and caregivers at the beginning and throughout their treatment journey.”

-Ends-

UK media contacts:

Helen Brown                                                                           Joshua Vine-Lott

AbbVie UK                                                                              Aurora Healthcare Communications

T: +44 (0)7929087878                                                            T: +44 (0)7543 222552

E: helen.l.brown@abbvie.com                                             E: Joshua.vine-lott@auroracomms.com

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in Google Play or Apple AppStores. Adverse events should also be reported to AbbVie at GBPV@abbvie.com.

The final SMC guidance can be accessed via the SMC website.

This is not a complete summary of all safety information. See Produodopa (foslevodopa/foscarbidopa) full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc (Great Britain) or www.emcmedicines.com (Northern Ireland).

NOTES TO EDITORS:

About Parkinson’s disease

There are approximately 153,000 people with Parkinson’s disease in the UK, with 12,400 of these people living in Scotland.^4,5 Every week, 30 people in Scotland are diagnosed with Parkinson’s disease, which is a progressive and chronic condition.^4,5 Parkinson’s disease is characterised by tremor, muscle rigidity, slowness of movement and difficulty with balance.⁶ It is classified as a movement disorder resulting from the loss of dopamine-producing brain cells.⁷

The motor symptoms of Parkinson’s disease begin when approximately 60-80% of the dopamine-producing cells in the brain are lost and symptoms continue to worsen slowly over the course of time.  While there is no known cure for the disease, there are treatments available to help reduce symptoms.¹⁴

As Parkinson’s disease progresses, patients tend to experience greater disability and an impaired ability to perform activities of daily living, as well as fluctuating responses to standard treatment, delayed gastric emptying and poor symptom control.¹⁵

About foslevodopa-foscarbidopa

Foslevodopa-foscarbidopa is a solution of levodopa and carbidopa prodrugs for continuous subcutaneous infusion via a pump 24 hours a day for the treatment of advanced levodopa responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.¹¹ Foslevodopa-foscarbidopa can be self-administered, or administered with the assistance of a caregiver.¹¹

About the M15-741 and M15-736 Phase 3 clinical trials

Foslevodopa-foscarbidopa has been studied in two pivotal Phase 3 clinical studies:

M15-736 is a Phase 3, randomised, double-blind, double-dummy, active-controlled study of continuous, subcutaneous infusion of foslevodopa-foscarbidopa plus oral placebo versus oral immediate-release levodopa-carbidopa plus continuous, subcutaneous infusion of placebo in patients with advanced levodopa-responsive Parkinson's disease inadequately controlled on current therapy, including at least 2.5 hours average daily “Off” time.3

The 12-week study met its primary efficacy endpoint of a statistically significant increase in “On” time without troublesome dyskinesia. Patients who received 24 hours/daily foslevodopa-foscarbidopa had more "On" time without troublesome dyskinesia, compared to oral levodopa/carbidopa [p=0·0083]. These patients also had less "Off" time compared to those who received oral levodopa/carbidopa [p=0·0054].3

The most frequent adverse events in the foslevodopa-foscarbidopa group were infusion site adverse events (erythema 20 [27%]), pain 19 [26%]), cellulitis (14 [19%]), and oedema (nine [12%]), most of which were non-serious and mild–moderate in severity. Six patients (8%) who received foslevodopa-foscarbidopa experienced a serious adverse event, the most frequent were catheter site cellulitis (one [1%]), infusion site cellulitis (one [1%]) and dehydration (one [1%]). Adverse events were reported in 63 (85%) of 74 patients in the foslevodopa-foscarbidopa group versus 42 (63%) of 67 in the levodopa- carbidopa group, and incidences of serious adverse events were similar between the groups (six [8%] of 74 vs four [6%] of 67, respectively. Adverse events led to premature discontinuation of study drug in 16 (22%) of 74 participants in the foslevodopa-foscarbidopa group versus one (1%) of 67 participants in the oral levodopa-carbidopa group.³

M15-741 was a Phase 3, open-label, single-arm study conducted to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of foslevodopa-foscarbidopa over 52 weeks in 244 patients. The study population was levodopa-responsive patients with Parkinson's disease whose motor symptoms that were inadequately controlled with current treatment who experienced a minimum of 2.5 hours of "Off" time per day as assessed by Parkinson's disease (PD) diaries. A total of 137 patients completed the study. The most common reasons for discontinuation were adverse events (26%) and withdrawal of consent (16%). Adverse events reported for ≥ 10% of subjects were infusion site events, hallucination, fall, anxiety and dizziness. The most common adverse events related to foslevodopa-foscarbidopa were infusion site events, which were non-serious, mild or moderate in severity and resolved.¹¹

The most common adverse events (AEs) were infusion site AEs, erythema (127 [52%]), nodule (70 [29%]), cellulitis (56 [23%]), oedema (47 [19%]), pain (38 [16%]), reaction (30 [12%]), and abscess (27 [11%]), followed by hallucination (42 [17%]) and fall (41 [17%]). Serious AE’s were reported in 63 (26%) patients, the most common were infusion site AEs, cellulitis (10 [4%]) and abscess (8 [3%]).¹⁶

About AbbVie in Neuroscience

At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information about AbbVie, please visit us at www.abbvie.co.uk.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on X (formerly Twitter) or YouTube.

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