Vigabatrin slated for advisory committee
Ovation's Sabril (vigabatrin) is going before FDA's Peripheral and Central Nervous System Drugs Advisory Committee for two epilepsy indications. GABA-transaminase inhibitor, which has a long 34-year history, will be reviewed Aug. 6-7 in Silver Spring, Md. Ovation is seeking approval for two indications, as adjunctive therapy for the treatment of refractory complex partial seizures in adults and treatment of infantile spasms. The firm said FDA had accepted the two NDAs for Sabril and granted priority review for the infantile indication in February. Ovation says now that it expects final approval by the end of the fourth quarter. The delay is nominal given that vigabatrin was originally deemed "approvable" by FDA in 1997 for adult seizures; the product was then owned by Aventis (now Sanofi-Aventis). One safety issue likely to be raised by the panel is a peripheral visual field defect
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FDA's advisory committee meeting for Ovation's GABA-transaminase inhibitor Sabril (vigabatrin) has been rescheduled for Jan. 7-8. The Peripheral and Central Nervous System Drugs Advisory Committee's review for two separate NDAs - one for adjunctive therapy for the treatment of refractory complex partial seizures in adults and one for treatment of infantile spasms - was originally scheduled for early August 2008 (1"The Pink Sheet," July 14, 2008, In Brief). The meeting was postponed after FDA was unable to find a pediatric neurologist to sit on the committee to replace Dartmouth Medical School's Greg Holmes, who was disqualified due to a conflict of interest. The conflict of interest issue caused FDA to miss the June 27 user fee date for both indications
FDA postpones two-day advisory committee meeting on Ovation's Sabril "due to difficulties in empanelling the necessary experts due to both scheduling conflicts and conflict-of-interest." The Peripheral and Central Nervous System Drugs Advisory Committee was scheduled to meet Aug. 6-7 to review vigabatrin as adjunctive therapy for the treatment of refractory complex partial seizures in adults and treatment of infantile spasms (1"The Pink Sheet," July 14, 2008, In Brief). Ovation expects to receive an "approvable" letter in late August, followed by a final decision by the end of the fourth quarter
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