The U.S. Food and Drug Administration has issued a Refuse to File (RTF) letter in response to Genzyme’s application for approval of alemtuzumab (Lemtrada) as a treatment for MS. The RTF letter requires that Genzyme reorganize the data presented and resubmit its application. Although no new data are required, the RTF is expected to delay any approval of the drug in MS by at least six months. The drug is currently under review by the European Medicines Agency.
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Combination therapy superior to monotherapy for psychotic depression
November 7, 2012A meta-analysis of 8 treatment trials (n=762) has concluded that a combination of an antidepressant with an antipsychotic agent is better than either alone in the treatment of psychotic depression (Farahani & Correll. J Clin Psychiatry 2012;73:486-496).
Botulinum toxin type A may be effective for trigeminal neuralgia
November 7, 2012About two-thirds of patients with trigeminal neuralgia (TN) may respond to injections of botulinum toxin type A (BTX-A), according to the results of a double-blind, placebo-controlled trial (Wu et al. Cephalalgia 2012;32:443-450).
Dopamine agonist withdrawal syndrome: Canadian study results
October 24, 2012A new Canadian study reports that dopamine agonist withdrawal syndrome (DAWS) is a potentially disabling complication associated with dopamine agonist use in patients with Parkinson’s disease (Pondal et al. J Neurol Neurosurg Psychiatry 2012; epublished August 29, 2012).