Allergan has done it. The FDA finally approved its wrinkle-fighter Botox as a treatment for migraines. The new indication could add $1 billion to its current annual sales of $1.3 billion, analysts say. "This is the most meaningful market expansion that the product has had since it was approved for cosmetic use," Piper Jaffray's David Amsellem tells Bloomberg.
The new indication is specifically for patients with chronic migraines; that amounts to about 3.2 million people in the U.S. "This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available," the FDA's Russell Katz says in a statement.
The expanded approval comes on the heels of an off-label marketing settlement between Allergan and the feds, in which the company agreed to pay $600 million to resolve claims that it had pushed Botox for unapproved uses--including migraine. And some aren't convinced that the evidence supports broad use of the drug for migraine sufferers, especially at a projected cost of $1,000 to $2,000. "The true drug effect is minimal," Jefferies analyst Corey Davis tells the New York Times.
However, Allergan is confident that Botox will capture plenty of the migraine market. It's also looking at more medical uses for the drug, EVP Scott Whitcup tells the NYT. "We call it our pipeline in a vial," Whitcup says. "People still think about it as a cosmetic product, but the therapeutic indications in the next five years will far surpass its cosmetic use." In fact, one the indications Allergan is studying for Botox is overactive bladder.
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