Allergan Inc., the Irvine drug maker, said Friday that British regulators approved its flagship Botox as a treatment for adults with chronic migraine headaches.
Britain is the first country that has cleared Botox for migraines, which will open up a new market for the drug, which is known as a wrinkle smoother as well as a treatment for various types of muscle spasms.
The approval is “a significant milestone in the history of Botox and Allergan,” said Scott Whitcup, Allergan’s executive vice president of research and development, in a statement.
Even with the British nod, U.S. approval for Botox for migraines isn’t guaranteed, analyst Aaron Gal of Sanford Bernstein & Co. told Reuters.
Earlier, Gal said that it was likely that the Food and Drug Administration would have a decision this month on whether the drug can be sold here for migraines.
He’s said that migraine treatment approval could eventually add $1 billion in annual sales to Botox, which Allergan projects to have sales of $1.33 billion to $1.37 billion this year.
Allergan said the approval is for patients who have headaches at least 15 days a month, including migraines on eight of those days.
