Allergan announced that the FDA approved Botox (onabotulinumtoxinA) for the prevention of headaches in adults with chronic migraine. Botox is the first prophylactic treatment to be approved by US regulators for this indication, the company noted.
The approval was based on data from Allergan's PREEMPT programme, which included two clinical trials that randomised 1384 patients to receive either Botox or placebo. In both studies, patients treated with Botox experienced a significantly greater decrease in the frequency of headache days from baseline. In addition, patients treated with Botox experienced a total cumulative reduction in headaches compared to placebo.
Botox generated $1.3 billion in sales last year, and Sanford C. Bernstein & Co. analyst Aaron Gal speculated that the migraine indication may add $1 billion in annual revenue.
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Reference Articles
Botox (onabotulinumtoxina) FDA approved as prophylactic treatment option for adult chronic migraine sufferers - (Allergan)
Allergan says US approves Botox as chronic migraine treatment - (Bloomberg)
FDA approves Botox for migraine headaches - (CNBC)
FDA approves Botox to treat chronic migraine - (FDA)
Allergan says FDA approves Botox as treatment for chronic migraine - (Stock Markets Review)
FDA approves Allergan's Botox to prevent migraines (free preview) - (The Wall Street Journal)
**Published in "First Word"
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