FDA approves Novartis' irritable bowel treatment

Thursday, July 25, 2002

BY ED SILVERMAN
Star-Ledger Staff

Novartis AG won approval yesterday for a treatment for irritable bowel syndrome for women, sending its shares up nearly 10 percent.

The decision, which was earlier than expected, is a boost for the Swiss drug maker, because the Zelnorm treatment is forecast to eventually become a billion-dollar blockbuster.

"This is a big deal," said Paulo Costa, who heads Novartis Pharmaceuticals Corp., the U.S. unit that is based in East Hanover and employs 3,500 people in New Jersey.

The company's American depository receipts rose $3.36 to $38.10.

The step comes shortly after regulators allowed Lotronex back on the market, although usage is restricted. The GlaxoSmithKline Plc treatment was withdrawn two years ago over serious side effects and several deaths.

Until Lotronex again became available, the estimated 10 million American women who are believed to suffer from irritable bowel syndrome didn't have any treatment options.

The moves by the Food and Drug Administration suggest the agency is attempting to become more responsive to consumers, one analyst said.

"There's a huge need that's not met," Ira Loss of Washington Analysis told Dow Jones Business News. "The FDA has obviously started to hear complaints they're too cautious."

The FDA delayed Zelnorm's approval while seeking data about alleged links to gallbladder surgery and ovarian cysts. Those concerns prompted Public Citizen, a consumer watchdog, to urge the FDA not to approve Zelnorm.

But the FDA said Zelnorm should be used on a short-term basis to increase stool movement through the bowels, which would reduce pain, bloating and constipation. The most common side effect is diarrhea.

"We're grateful it's been approved," said Jeff Roberts, co- founder of the IBS Self-Help Group, a patient advocacy group that pushed the FDA to approve Zelnorm and reconsider Glaxo's Lotronex.

Costa said Zelnorm will be available in September, but didn't disclose pricing.

Ed Silverman can be reached at [email protected] or (973) 392-1542.

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