Disease Analysis: Epilepsy
|出版日期||內容資訊||英文 78 Pages
|疾病分析:癲癇 Disease Analysis: Epilepsy|
|出版日期: 2020年01月08日||內容資訊: 英文 78 Pages||
Datamonitor Healthcare estimates that in 2018, there were 54.0 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 on 21 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, with Phase III topline data for its use in Lennox-Gastaut patients expected by the end of Q1 2020. Further notable future events include topline Phase III data for padsevonil in the first half of 2020 and for ganaxolone in rare pediatric epilepsy patients in 2021.