FINTEPLA's Continued Growth Offers Patients a Lifeline in the Fight Against Severe Epilepsy | DelveInsight

FINTEPLA has strong market potential due to its demonstrated efficacy in treating rare, severe epileptic syndromes like Dravet and Lennox-Gastaut, where treatment options are limited. With FDA and EMA approvals, it taps into a high-value orphan drug market. Continued global expansion and label extensions could significantly boost its commercial reach.
DelveInsight's "FINTEPLA Market Size, Forecast, and Market Insight Report [https://www.delveinsight.com/report-store/fintepla-drug-insight-and-market-forecast?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr]" highlights the details around FINTEPLA, an oral medication that is a low-dose solution of fenfluramine hydrochloride. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of FINTEPLA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

What is FINTEPLA?

FINTEPLA (previously known as ZX008) is an oral medication containing a low dose of fenfluramine hydrochloride. It works by limiting the influx of calcium ions into neurons, which helps reduce their hyperactivity and, in turn, decreases seizure frequency. Additionally, it stimulates serotonin receptors, enhancing its overall antiepileptic effect.

In the US, FINTEPLA is distributed exclusively through the FINTEPLA REMS program, a restricted access initiative. In the European Union, it is provided under a controlled access system mandated by the EMA to prevent its misuse for weight loss and to ensure that prescribing physicians are aware of the need for regular cardiac monitoring in patients using the drug.

Both the FDA and the European Union granted ODD to ZX008 in the treatment of LGS and Dravet Syndrome. Additionally, the FDA granted a priority review for the NDA for FINTEPLA for Dravet Syndrome. In May 2023, FINTEPLA received Orphan Drug designation in Japan.

FINTEPLA Dosage and Administration

Dravet Syndrome

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The treatment begins with a dose of 0.1 mg/kg twice daily, which can be increased weekly depending on how well the patient responds and tolerates the medication.

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The maximum maintenance dose is 0.35 mg/kg twice daily, not exceeding a total of 26 mg per day.

Lennox-Gastaut Syndrome

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The initial dose is 0.1 mg/kg twice daily and may be gradually increased each week based on tolerability.

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The target maintenance dose is 0.35 mg/kg twice daily, with a maximum daily dose of 26 mg.

For Both Dravet and Lennox-Gastaut Syndromes

When used in combination with stiripentol and clobazam, the maximum maintenance dose should be reduced to 0.2 mg/kg twice daily, up to a maximum of 17 mg per day.

Dosage Adjustments

Modifications to the dosage are advised for patients who:

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Are taking strong CYP1A2 or CYP2D6 inhibitors

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Have severe renal impairment

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Have mild to severe liver impairment

FINTEPLA at a Glance

Drug Name: FINTEPLA (fenfluramine)

Developer: UCB

Molecule Type: Small molecule

First Approval Year:

US: 2020 (Dravet syndrome), 2022(LGS)

EU: 2020 (Dravet syndrome), 2023 (LGS)

JP: 2022 (Dravet syndrome), 2024 (LGS)

FINTEPLA Indication: Seizures associated with Dravet syndrome in patients 2 years of age and older or Seizures associated with LGS in patients 2 years of age and older

Mechanism of action: Serotonin 5HT-2 receptor agonist

Route of administration: Oral

Developmental and epileptic encephalopathies (DEE) represent a group of severe neurological disorders characterized by early-onset epilepsy and developmental impairments, often leading to substantial cognitive challenges. As per DelveInsight's estimates, there were around 287,000 diagnosed prevalent cases of DEE across the 7MM in 2024. This number is anticipated to grow over the forecast period (2025-2034), driven by increasing rates of neurological conditions like epilepsy and contributing factors such as environmental influences and maternal health issues.

The US FDA has approved several treatments for related conditions like Lennox-Gastaut Syndrome (LGS), Dravet Syndrome, and CDKL5 Deficiency Disorder. These include a variety of drug classes such as sodium channel modulators, GABA receptor modulators, calcium channel blockers, and receptor antagonists. Notable anti-epileptic drugs (AEDs) currently available include FINTEPLA, EPIDIOLEX, TOPAMAX, BANZEL, LAMICTAL, FELBATOL, ONFI, KLONOPIN, DIACOMIT, SABRIL, among others.

In 2024, the DEE market across the 7MM was valued at approximately USD 2.3 billion. This market is projected to expand by 2034, supported by increased use of existing therapies through label expansions and the launch of new treatment options.

Emerging Competitors of FINTEPLA

The DEE pipeline features several drug candidates, including EPX-100 from Harmony Biosciences, Bexicaserin from Lundbeck, Zorevunersen developed by Stoke Therapeutics and Biogen, and Relutrigine from Praxis Precision Medicines, among others. In August 2024, the FDA lifted a partial clinical hold, allowing the advancement of Zorevunersen (STK-001) into a Phase III registrational trial for children and adolescents with Dravet syndrome. Additionally, in July 2024, Longboard Pharmaceuticals announced that the FDA had granted Breakthrough Therapy designation to Bexicaserin for treating seizures linked to developmental and epileptic encephalopathies (DEEs) in patients aged 2 and above.

To know more about the number of competing drugs in development, visit @ FINTEPLA Approval [https://www.delveinsight.com/sample-request/fintepla-drug-insight-and-market-forecast?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr]

Key Milestones of FINTEPLA

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In April 2024, FINTEPLA was approved by the Japanese Ministry of Health, Labor, and Welfare (MHLW) for the treatment of seizures associated with LGS as an add-on therapy to other antiepileptic medicines for patients two years of age and older.

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In February 2023, FINTEPLA was approved in the European Union for the treatment of seizures associated with LGS as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

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In September 2022, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved FINTEPLA for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older

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In March 2022, UCB announced the US FDA approval of FINTEPLA for the treatment of seizures associated with LGS in patients 2 years of age and older.

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In December 2020, the European Commission granted marketing authorization for FINTEPLA for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.

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In June 2020, the US FDA approved FINTEPLA to treat seizures associated with Dravet syndrome in patients 2 years of age and older.

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In March 2019, Zogenix entered into an exclusive distribution agreement with Nippon Shinyaku for the commercialization of FINTEPLA in Japan.

Discover how FINTEPLA is shaping the DEE treatment landscape @ FINTEPLA Cost [https://www.delveinsight.com/sample-request/fintepla-drug-insight-and-market-forecast?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr]

FINTEPLA Market Dynamics

FINTEPLA is a prescription medication approved for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome (LGS), two rare and severe forms of epilepsy. The market dynamics surrounding FINTEPLA are driven by the drug's niche indication, strong clinical efficacy, and evolving regulatory landscape. As a rare disease treatment, FINTEPLA benefits from orphan drug designation in key markets such as the US and Europe, which confers market exclusivity and incentivizes its continued development and commercialization. These factors collectively create a relatively protected market space with limited direct competition, enabling premium pricing and specialized market positioning.

The market potential of FINTEPLA is significantly shaped by the unmet needs in Dravet and LGS patient populations. Traditional antiepileptic drugs (AEDs) often fail to provide adequate seizure control in these syndromes, creating demand for innovative therapies. FINTEPLA has demonstrated robust efficacy in reducing seizure frequency, leading to improved patient quality of life. These clinical advantages have supported its uptake among neurologists and epilepsy specialists, although its use is carefully managed due to its historical association with cardiac valvulopathy when used as an appetite suppressant. However, the safety profile in the epilepsy indication, under stringent risk evaluation and mitigation strategies (REMS), has been acceptable, supporting its adoption.

Market access and reimbursement dynamics play a critical role in FINTEPLA's commercial performance. Payers are typically receptive to covering high-cost therapies for rare diseases when clear clinical value is demonstrated. Nevertheless, securing and maintaining favorable reimbursement remains a challenge, especially as healthcare systems globally face mounting cost pressures. Companies must actively engage in health economics and outcomes research (HEOR) to justify the drug's value proposition. Additionally, geographic expansion and regulatory approvals in new territories are important levers for growth, with particular attention on emerging markets that may have delayed access due to regulatory and pricing hurdles.

Competitive dynamics are gradually intensifying, with pipeline therapies targeting similar epileptic syndromes, including genetic therapies, other antiepileptic drugs, and neuromodulation approaches. However, given the complexity of epilepsy treatment and the typically multidrug regimen, FINTEPLA can potentially coexist with other therapies rather than be displaced outright. Strategic collaborations, real-world evidence generation, and life-cycle management (e.g., label expansion or pediatric formulations) will be vital for sustaining long-term market relevance. Overall, FINTEPLA's market outlook remains favorable within its targeted niche, provided continued attention to safety monitoring, payer engagement, and evolving therapeutic landscapes.

Table of Contents

1. Report Introduction

2. FINTEPLA: UCB

2.1. Product Overview

2.2. Other Development Activities

2.3. Clinical Development

2.4. Clinical Trials Information

2.5. Safety and Efficacy

2.6. Product Profile

2.7. Market Assessment

2.7.1. The 7MM Analysis

2.7.1.1. Cost Assumptions and Rebate

2.7.1.2. Pricing Trends

2.7.1.3. Analogue Assessment

2.7.1.4. Launch Year and Therapy Uptake

2.7.2. The United States Market Analysis

2.7.3. EU4 and the United Kingdom Market Analysis

2.7.3.1. Germany

2.7.3.2. France

2.7.3.3. Italy

2.7.3.4. Spain

2.7.3.5. UK

2.7.4. Japan Market Analysis

2.8. Market Drivers

2.9. Market Barriers

2.10. SWOT Analysis

3. Key Cross of Marketed Competitors of FINTEPLA

4. Key Cross of Emerging Competitors of FINTEPLA

Related Reports

Developmental and Epileptic Encephalopathies Market [https://www.delveinsight.com/report-store/developmental-and-epileptic-encephalopathies-dee-market?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr]

Developmental and Epileptic Encephalopathies Market Insights, Epidemiology, and Market Forecast - 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key DEE companies, including vid Therapeutics, Stoke Therapeutics, Biogen, Harmony Biosciences, Lundbeck (Longboard Pharmaceuticals), Praxis Precision Medicines, SK Life Science, Cerecin Neurosciences, Encoded Therapeutics, Praxis Precision Medicines, among others.

About DelveInsight

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