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.
Neurology
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).
Aubade for Aubagio: FDA approves teriflunomide in RRMS
October 24, 2012The U.S. Food and Drug Administration has approved the use of oral teriflunomide (Aubagio) 7 or 14 mg/day for the treatment of relapsing forms of MS. The drug was submitted for FDA review in October 2011. The drug has not yet been approved by Health Canada.
Small, short-term benefit with physiotherapy in PD: meta-analysis
October 24, 2012A Cochrane meta-analysis has examined 33 trials (n=1,518) to determine the benefits of physiotherapy versus no physiotherapy in patients with Parkinson’s disease (Tomlinson et al. Cochrane Database Syst Rev 2012 Aug 15;8:CD002817). Interventions included general physiotherapy, exercise, treadmill training, dance and martial arts.