Approval of Allergan's Botox for migraine 'a headache for regulators and payers,' says Datamonitor

Decisions from US and European regulators on the use of Allergan's wrinkle reducer Botox (onabotulinumtoxin A) for the prophylactic treatment of chronic migraine are eagerly anticipated following UK approval this month (The Pharma Letter July 12). However, independent market analyst Datamonitor suggests that approval is far from guaranteed and assuming a positive outcome, reimbursement challenges will provide Allergan with an ongoing headache.

Martin Adams, health care analyst at Datamonitor comments that 'Approval in the UK for Allergan's Botox for the prevention of chronic migraine bodes well for the US and other European Union filings but even so there remain significant hurdles for the company to overcome.'

Under direction from the UK Medicines and Healthcare Products Regulatory Agency (MHRA), Botox will only be available for patients who suffer headaches for at least 15 days a month, half of which must be attributable to a migraine. However, it is widely acknowledged that Botox is unlikely to be effective in all patients experiencing chronic migraine, and predicting which patients will respond favourably to the treatment will undoubtedly represent a significant and expensive challenge for physicians. Furthermore, the drug also failed to meet the primary efficacy endpoint in the first Phase III trial and, whilst generally perceived to be safe, has the potential to cause serious life-threatening side effects.