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FDA approves Ironwood’s irritable bowel drug

Ironwood Pharmaceuticals Inc. says it is on track to start selling a treatment for chronic constipation and irritable bowel syndrome in adults, following Thursday’s approval by the Food and Drug Adminstration.

The highly anticipated pill, called Linzess, will be the first product developed by the 14-year-old Cambridge company to hit the market. The FDA approval was expected, but most observers had predicted it would come next month.

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With tens of millions of people affected by the debilitating conditions, analysts say Linzess could be a blockbuster, capable of pulling in more than $1 billion in annual worldwide sales within a decade.

“It’s great to be at the commercial starting line,” Ironwood chief executive Peter Hecht said Thurday. “There’s a lot of work that goes into the launch of a product that can help so many patients — and we’re ready to go.”

Corey Davis, a specialty pharmaceuticals analyst for New York investment firm Jeffries & Co., said Linzess “checks all the boxes that you would want for an ideal, blockbuster drug.” Namely, he said, it has a huge patient population, is easy for doctors to prescribe and for patients to take, and has been shown to be extremely effective.

“You stop taking the pill and [physical distress] comes back immediately . . . so there’s really good incentive to stay on the pill once a day,” Davis said. “I would say this is easily a $2 billion product in 10 years.”

Despite such financial projections, Hecht spoke mostly about what the drug would do for patients. About 63 million people suffer from chronic constipation, and another 15.3 million are affected by irritable bowel syndrome, or IBS, according to National Institutes of Health statistics cited by the FDA.

‘You stop taking the pill and [physical distress] comes back immediately . . . so there’s really good incentive to stay on the pill once a day.’

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“What we can bring to the market with Linzess is a drug that has demonstrated meaningful pain relief,” Hecht said.

Ironwood has not settled on a price but said the drug could go for about $6 or $7 a day, the same amount that similar treatments already available cost.

The company has partnered with Forest Laboratories Inc., a New York drug maker with a strong network of sales representatives that Ironwood hopes will help it reach physicians and patients.

FDA spokeswoman Stephanie Yao said the agency saw no reason to wait until September to grant approval once Linzess had been properly vetted by regulators.

“We want options out there for people, so when we receive an application and upon review we find the drug is safe and effective, then we go head and approve it,” said Yao said, adding that the agency has been working to become more efficient. Pharmaceutical companies have long complained that the FDA takes too long to act on applications for new drugs.

Erin Ailworth can be reached at Follow her on Twitter @ailworth.
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