The Year in Neurology: Studies Not to Miss From 2011

Andrew N. Wilner, MD


November 23, 2011

In This Article

A Look Back: Introduction

2011 has been a very exciting year for neurologists and their patients. Advances in basic science and disciplined clinical trials have led to drug approvals for the prevention of stroke and treatment of epilepsy. In addition, at least 2 oral drugs for relapsing-remitting multiple sclerosis, BG-12 and teriflunomide, boast positive results from phase 3 trials and are poised for approval by the US Food and Drug Administration (FDA).

In 2010, the FDA approved dabigatran, a thrombin inhibitor, for anticoagulation in patients with nonvalvular atrial fibrillation. In November 2011, the FDA approved rivaroxaban, a once-daily oral factor Xa inhibitor, for the same indication. Another factor Xa inhibitor, apixaban, recently demonstrated superior results to warfarin in preventing stroke or systemic embolism, with less bleeding and lower mortality, and may soon be approved as well.[1]

Yet another drug joins the "new" antiepileptic drugs, which now total 14 since the 1993 approval of felbamate. Clobazam, a 1,5 benzodiazepine, was approved for the adjunctive treatment of seizures in patients with Lennox-Gastaut syndrome. This drug belongs to the same class of drugs as diazepam and lorazepam but exhibits particular efficacy for drop attacks.

Winning FDA drug approval is not easy, as was seen this year in multiple sclerosis. The goal of US approval for cladribine, a potent but potentially toxic oral drug for multiple sclerosis, was abandoned by Merck despite approvals in Russia and Australia.[2] Laquinimod, a novel oral immunomodulator with both anti-inflammatory and neuroprotective properties, failed to meet its primary endpoint of reduced annualized relapse rate in its most recent phase 3 trial (BRAVO).[3] Consequently, its application for FDA approval has been delayed until more supporting data can be obtained in a new trial.[4] But progress in multiple sclerosis moves forward: A new drug application for teriflunomide was accepted for review in October 2011, and data from BG-12 are expected to be filed shortly.


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