FDA advisory panel backs GlaxoSmithKline/Valeant's epilepsy drug Potiga

A US Food and Drug Administration advisory committee has voted unanimously to recommend UK drugs giant GlaxoSmithKline and Valeant Pharmaceuticals' Potiga (ezogabine) as adjunctive treatment for adults with partial-onset seizures.

After a review of the safety data, including urinary retention, infection and kidney stones, the majority of Committee members voted that urinary retention could be mitigated by patient monitoring and discussed how this could be addressed. The Committee also voted unanimously that monitoring should not be instituted for infection and kidney stones.

"We are encouraged by the Advisory Committee's assessment of the efficacy and safety of ezogabine and await a decision by the FDA," said Atul Pande, senior vice president, Neurosciences Medicines Development Center, North America Pharmaceuticals, GSK, adding: "For appropriate patients, we believe ezogabine could offer an important adjunctive treatment option for partial-onset seizures that are not well-controlled."