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Mar 14, 2011
 |  BioCentury  |  Regulation

History Lesson

FDA panel backs historical controls to expand epilepsy labels to monotherapy

From a regulatory standpoint, historical controls have traditionally been good for little more than supportive evidence alongside single-arm cancer studies or as inputs for calculating non-inferiority margins. Now, an FDA advisory panel's recommendation could make supplemental applications for epilepsy monotherapy the only setting in which a drug can be approved using a historical-controlled trial.

Last week, FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 14-0 that if an epilepsy drug has already shown efficacy as an adjunct treatment, historical controls are acceptable for subsequent monotherapy studies.

Only four drugs have been approved as monotherapies for partial seizures. All of these were label expansions, and all were based on trials using so-called pseudo-placebo controls, which consist of a suboptimal dose of either the study drug or another approved treatment.

Due to the risk of injury caused by seizures in patients treated with a suboptimal dose, clinicians have been reluctant to enroll patients in pseudo-placebo trials. Over time, this...

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