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Datamonitor: GlaxoSmithKline/Valeant - boost for Potiga ahead of final FDA review
Potiga, GlaxoSmithKline and Valeant's first-in-class potassium channel activator for epilepsy, has received a positive opinion from an FDA advisory panel, which reached a unanimous consensus on its efficacy. FDA approval now seems likely and Datamonitor forecasts peak sales of almost $300m in 2017, prolonging GlaxoSmithKline's share of the $3 billion epilepsy market.
GlaxoSmithKline and Valeant's novel antiepileptic drug Potiga (ezogabine) received a boost when an FDA advisory committee voted unanimously that the drug was effective as an adjunctive treatment in patients with partial onset seizures. Furthermore, the panel also concluded that the risk of urinary retention associated with the treatment could be successfully mitigated. This recommendation will help guide the FDA's decision, which is expected by August 30, 2010.
Despite a plethora of available antiepileptic drugs, significant unmet need exists in the treatment of epilepsy. It is estimated that as many as 30% of patients with partial-onset seizures remain refractory to current treatments, which typically target sodium channels, glutamate receptors or GABA receptors. Potiga is a first-in-class activator of potassium channels and the novel mode of action potentially offers benefit to treatment refractory patients. Potiga's Phase III RESTORE trials demonstrate impressive efficacy in this population, with the drug producing 44% reduction in seizure frequency and a responder rate of 45% at the highest investigated dose.
Given the drug's mode of action and efficacy in a patient population with high unmet need, Datamonitor forecasts Potiga to achieve peak annual sales of almost $300m across the seven major markets in 2017.
However, Potiga must be dosed three times daily, which is a hindrance to patient compliance. Physicians may be reluctant to prescribe the drug when once- or twice-daily treatments are available, considering the risk associated with noncompliance. Potiga's label would represent another barrier to uptake, with the drug expected to be restricted to adjunctive use only. Monotherapy is the ultimate goal for an antiepileptic drug, although trials required to gain approval in this indication are expensive. Greater revenues could also be possible should GlaxoSmithKline seek indication expansions in other CNS-related disorders, a common strategy employed by antiepileptic drug developers.
Nevertheless, Potiga will become an important part of the armamentarium for epilepsy pharmacotherapy (albeit it later in the treatment algorithm) and will be welcomed by patients and physicians alike. Additionally, the drug will expand GlaxoSmithKline's share of the $3 billion epilepsy market. The British drugmaker's stake in this sector has waned following the loss of market exclusivity for Lamictal (lamotrigine), despite the company's lifecycle management strategy with the launch of an extended-release formulation, Lamictal XR.
Datamonitor: Pipeline Insight: Epilepsy - Past successes hard to emulate in highly genericized market
Datamonitor: GlaxoSmithKline plc: PharmaVitae Profile
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