Botox gets EU green light as bladder treatment

Last week, Allergan CEO David Pyott was talking up a new indication for the wrinkle drug Botox, quoting analyst estimates that it could add hundreds of millions to annual sales. This week, Irish regulators have opened the gate. The Irish Medicines Board gave Botox a positive opinion as a treatment for urinary incontinence caused by spinal cord injury or multiple sclerosis.

The endorsement is based on a Phase III study that showed Botox injections reduced involuntary bladder contractions and increased capacity, helping to prevent urine leakage, even stopping it altogether in some patients, the company said. Now, the drug is eligible for marketing licenses in 14 European countries that work under the EU's mutual recognition rules. "Our task now is to work closely with the national health authorities to secure the relevant national licenses so that we can bring this valuable treatment option to patients, as quickly as possible," Allergan European President Douglas Ingram said in a statement.

The company has applied for U.S. approval for the same indication and expects a decision later this year. And as Pyott said last week, Allergan will then work toward broader use of Botox against overactive bladder. Besides its use as a cosmetic drug, which brings in about half of annual sales, Botox is also approved for use against muscle spasticity and migraines.

- read the release from Allergan
- get the Reuters news

Related Articles
Multitalented Botox could get $500M off bladder indication
Topped out as a cosmetic, Botox goes theraputic

Suggested Articles

BMS’s Opdivo has plenty of competition in its current bladder cancer indication—so it’s hoping to strike out on its own in a new area of the disease.

The Japanese approval, under the brand name Jyseleca, came a month after an FDA complete response letter that asked Gilead for more data.

The Trump Administration has opened the doors for Florida and other states to import prescription drugs from Canada—despite industry objections.