Disease Analysis: Epilepsy
Author: Daniel Digaudio
Publisher: Datamonitor Healthcare
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Latest key takeaways
- Datamonitor Healthcare estimates that in 2019, there were 54.6 million prevalent cases of active epilepsy worldwide, and forecasts that number to increase to 59.0 million prevalent cases by 2027.
- The traditional anti-epileptic drug (AED) market is highly genericized and there are limited branded AEDs left without generic equivalents. Additionally, though these newer branded AEDs differentiate themselves from older ones, there are still unmet needs in this market that need to be addressed, including refractory epilepsy and rare specific epilepsy.
- The partial-onset seizure (POS) market represents the largest market in the epilepsy disease space, however, it is highly saturated with an extensive repertoire of anticonvulsants available for prescription. Leading drugs in this patient segment are the broad-label leaders, Keppra/Keppra XR and Lamictal/Lamictal XR. Although GlaxoSmithKline has managed to slow the ensuing generic erosion of Lamictal/Lamictal XR, UCB has not been so successful with Keppra/Keppra XR and sees significant sales only remaining in Japan.
- Keppra/Keppra XR and Lamictal/Lamictal XR sales will continue to plummet as increasing numbers of generic levetiracetam and lamotrigine drugs threaten their respective market shares. Brand and company reputation will help to offset the decrease in sales, particularly with Lamictal/Lamictal XR, but ultimately opportunities for follow-on successors such as Vimpat and Fycompa will open for these drugs to become brands of choice for prescribers. UCB will continue to encourage physicians to opt for its newer branded products, Briviact or Vimpat, in order to maintain its market-leading position in the epilepsy space.
- The breadth of each epilepsy drug’s product label is highly pertinent to its competitive edge and provides impetus for the ongoing uptake of branded anti-epileptics. Even in the saturated POS market, numerous label expansions broadening POS drug usage to monotherapy use and the treatment of pediatric patients are likely to bolster uptake. Further expansion to generalized and secondary generalized seizures, specific subpopulations such as refractory epilepsy patients, and rare pediatric epilepsy patients may also help to maximize commercial potential.
- Despite rare niche epilepsy syndromes containing much smaller patient populations, companies which successfully achieve approval and marketing for drugs in these indications should see a high return on investment. Few drugs have been specifically approved for these niche indications, justifying higher drug prices for what are such devastating diseases. Epidiolex, for instance, has minimal competition and is indicated for several of these niche indications, and consequently is bringing in large profits for GW Pharmaceuticals.
- The most pressing unmet needs in the epilepsy area appear to have remained consistent over the past several years. Primary unmet needs include additional treatment options for refractory epilepsy patients, effective medicines for specific epilepsy syndromes such as PCDH19 epilepsy and CDKL5 syndrome, and better ways to manage common comorbidities afflicting epilepsy patients.
- In the past year UCB released positive topline Phase III results for Vimpat in patients with primary generalized tonic-clonic seizures, thus working towards the goal of extending Vimpat’s label. This is part of UCB’s strategy so that the drug may succeed Keppra/Keppra XR as a broad-label epilepsy market leader and help maintain the company’s large market share in the wider epilepsy space.
- SK Biopharmaceuticals’ Xcopri was approved by the FDA for the treatment of POS epilepsy in adults in November 2019. The drug exhibited cases of drug reaction with eosinophilia and systemic symptoms (DRESS) in Phase II clinical trials. However, results from a large Phase III open-label extension study of Xcopri as an adjunctive treatment in POS epilepsy patients have shown that a slower titration rate than that utilized in earlier studies mitigates the risk of DRESS syndrome occurring. These results permitted the omission of a black box warning for DRESS syndrome on Xcopri’s prescribing information. Xcopri’s Phase II efficacy data are extremely encouraging in refractory epilepsy patients and in achieving seizure freedom.
- In the near future, there are several key events expected in the epilepsy space. Fintepla is set to receive a CHMP opinion for its use in the EU to treat Dravet syndrome patients, and a PDUFA decision has been extended until the end of June 2020. Further notable future events include topline Phase III data for padsevonil, and for ganaxolone in rare pediatric epilepsy patients in 2021.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Patient segmentation
10 Risk factors
10 Diagnosis
12 TREATMENT
12 Treatment guidelines
14 Drug approaches
15 Non-drug approaches
16 EPIDEMIOLOGY
16 Prevalence methodology
19 MARKETED DRUGS
26 PIPELINE DRUGS
33 KEY REGULATORY EVENTS
33 Interview: Arvelle Aims To Be Major Player In CNS
33 GW’s Cannabidiol Drug To Be Funded In England For Epilepsy
33 Major Milestone For SK Biopharm As Anti-Epileptic Gets US Approval
33 Pent-Up Demand As GW Pharma’s Epidyolex Approved In Europe
33 Seizure Drugs: Adult Efficacy Data May Be Extrapolated To Pediatric Patients
35 PROBABILITY OF SUCCESS
36 LICENSING AND ASSET ACQUISITION DEALS
36 Bloom Licenses Bacterial IP From Duke For Therapeutic Investigation
36 Deals Shaping The Medical Industry, December 2019
36 Neurocrine Adds Epilepsy Assets From Xenon
37 CLINICAL TRIAL LANDSCAPE
38 Sponsors by status
39 Sponsors by phase
40 Recent events
42 DRUG ASSESSMENT MODEL
44 MARKET DYNAMICS
45 FUTURE TRENDS
45 Drugs approved for rare pediatric epilepsies will deliver large revenues for respective companies
45 Large POS market is highly saturated and will be difficult to penetrate
46 Key epilepsy player UCB will follow new strategies and lifecycle management to maintain market share
47 CONSENSUS FORECASTS
52 RECENT EVENTS AND ANALYST OPINION
52 OV935 for Seizure Disorders (Epilepsy) (March 30, 2020)
53 Padsevonil for Partial Seizures (Epilepsy) (March 13, 2020)
54 Staccato Alprazolam for Partial Seizures (Epilepsy) (March 12, 2020)
56 Fintepla for Lennox-Gastaut Syndrome (LGS; Epilepsy) (February 6, 2020)
57 Ganaxolone for Seizure Disorders (Epilepsy) (September 26, 2019)
59 OV935 for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 23, 2019)
61 Zygel for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 18, 2019)
63 E2082 for Partial Seizures (Epilepsy) (July 30, 2019)
65 Vimpat for Partial Seizures (Epilepsy) (June 30, 2019)
66 Lamictal for Epilepsies (June 25, 2019)
67 Fintepla for Dravet Syndrome (Epilepsy) (May 30, 2019)
68 Lyrica for Partial Seizures (Epilepsy) (May 24, 2019)
69 STK-001 for Dravet Syndrome (Epilepsy) (May 23, 2019)
70 Valtoco for Seizure Disorders (Epilepsy) (May 5, 2019)
72 KEY UPCOMING EVENTS
73 KEY OPINION LEADER INSIGHTS
73 Refractory epilepsy patients
73 Rare pediatric epilepsies
73 Pipeline epilepsy prospects
75 UNMET NEEDS
76 BIBLIOGRAPHY
76 Prescription information
78 APPENDIX
LIST OF FIGURES
9 Figure 1: ILAE 2017 Classification of Seizure Types: Basic Version
12 Figure 2: Levels of efficacy and effectiveness evidence supporting use of AEDs in epilepsy subpopulations
14 Figure 3: Recommendations for monotherapy in adults with new-onset epilepsy with focal epilepsy or unclassified tonicclonic seizures
15 Figure 4: Drug approaches for treating the various types of epilepsy
18 Figure 5: Trends in prevalent cases of active epilepsy, 2018–27
26 Figure 6: Overview of pipeline drugs for epilepsy in the US
26 Figure 7: Pipeline drugs for epilepsy, by company
27 Figure 8: Pipeline drugs for epilepsy, by drug type
27 Figure 9: Pipeline drugs for epilepsy, by classification
35 Figure 10: Probability of success in the epilepsy pipeline
37 Figure 11: Clinical trials in epilepsy
37 Figure 12: Top 10 drugs for clinical trials in epilepsy
38 Figure 13: Top 10 companies for clinical trials in epilepsy
38 Figure 14: Trial locations in epilepsy
39 Figure 15: Epilepsy trials status
40 Figure 16: Epilepsy trials sponsors, by phase
42 Figure 17: Datamonitor Healthcare’s drug assessment summary for epilepsy
44 Figure 18: Market dynamics in epilepsy
45 Figure 19: Future trends in epilepsy
54 Figure 20: Padsevonil for Partial Seizures (Epilepsy) (March 13, 2020): Phase IIb – ARISE
56 Figure 21: Staccato Alprazolam for Partial Seizures (Epilepsy) (March 12, 2020): Phase IIb – StATES
57 Figure 22: Fintepla for Lennox-Gastaut Syndrome (LGS; Epilepsy) (February 6, 2020): Phase III – Adjunctive Therapy
59 Figure 23: Ganaxolone for Seizure Disorders (Epilepsy) (September 26, 2019): Phase II – Status Epilepticus
61 Figure 24: OV935 for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 23, 2019): Phase II – ENDYMION(OLE)
63 Figure 25: Zygel for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 18, 2019): Phase II – BELIEVE 1 (DEE)
66 Figure 26: Vimpat for Partial Seizures (Epilepsy) (June 30, 2019): Phase III – VALOR (PGTC Seizures)
69 Figure 27: Lyrica for Partial Seizures (Epilepsy) (May 24, 2019): Phase III – PGTC (Grand Mal) Seizures
72 Figure 28: Key upcoming events in epilepsy
LIST OF TABLES
17 Table 1: Prevalent cases of active epilepsy, 2018–27
20 Table 2: Marketed drugs for epilepsy
28 Table 3: Pipeline drugs for epilepsy
48 Table 4: Historical global sales, by drug ($m), 2014–18
50 Table 5: Forecasted global sales, by drug ($m), 2020–24
52 Table 6: OV935 for Seizure Disorders (Epilepsy) (March 30, 2020)
53 Table 7: Padsevonil for Partial Seizures (Epilepsy) (March 13, 2020)
55 Table 8: Staccato Alprazolam for Partial Seizures (Epilepsy) (March 12, 2020)
56 Table 9: Fintepla for Lennox-Gastaut Syndrome (LGS; Epilepsy) (February 6, 2020)
58 Table 10: Ganaxolone for Seizure Disorders (Epilepsy) (September 26, 2019)
60 Table 11: OV935 for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 23, 2019)
61 Table 12: Zygel for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 18, 2019)
64 Table 13: E2082 for Partial Seizures (Epilepsy) (July 30, 2019)
65 Table 14: Vimpat for Partial Seizures (Epilepsy) (June 30, 2019)
66 Table 15: Lamictal for Epilepsies (June 25, 2019)
67 Table 16: Fintepla for Dravet Syndrome (Epilepsy) (May 30, 2019)
68 Table 17: Lyrica for Partial Seizures (Epilepsy) (May 24, 2019)
69 Table 18: STK-001 for Dravet Syndrome (Epilepsy) (May 23, 2019)
70 Table 19: Valtoco for Seizure Disorders (Epilepsy) (May 5, 2019)
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