June 25, 2018
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Botox Wins FDA Approval for Urinary Incontinence

By Molly Peterson, Bloomberg News

WASHINGTON — Allergan won U.S. clearance Wednesday to market the wrinkle smoother Botox as a treatment for urinary incontinence.

The Food and Drug Administration approved the drug for people with overactive bladders who have neurologic conditions such as multiple sclerosis and spinal cord injuries, the agency said in a statement. The medicine is injected into the bladder to increase its capacity by relaxing muscles.

Botox, also used to reduce facial wrinkles and treat neurological disorders, is the Irvine, Calif.-based company’s top product with $1.4 billion in revenue last year. Sales of the drug for incontinence in people with MS and spinal cord injuries may reach $40 million in 2017, Seamus Fernandez, a Boston-based analyst at Leerink Swann, said in a note to investors.

“This approval of Botox is an important milestone in Allergan’s commitment to develop and make available novel treatment options for urologists and their patients,” Scott Whitcup, Allergan’s chief scientific officer and executive vice president for research and development, said in a statement.

The approval may bode well for eventual FDA clearance of Botox for idiopathic overactive bladder, a more common condition that may boost the drug’s sales by $210 million in 2017, Fernandez said. He said he expects Allergan to seek FDA clearance for that use next year, he said.

Botox, a purified form of the poison botulinum that blocks connections to nerves, won FDA approval in October as a treatment for chronic migraine headaches.

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