Updated from 6:19 p.m. EST
suffered a pair of setbacks Monday as U.S. regulators again delayed acting on an experimental obesity drug and also restricted the use of a controversial antibiotic.
After the U.S. markets closed, the French drug giant said the Food and Drug Administration won't rule on the obesity drug Acomplia until July 27. The most recent deadline had been set for late April.
The April deadline represented a
90-day delay from an action date that had been scheduled for February.
Twelve months ago, the FDA granted
conditional approval for Acomplia as a weight-loss drug, but the company hasn't disclosed what conditions must be met for full approval.
Analysts say Acomplia is the company's
most promising product in a research pipeline they view as weak. Despite the U.S. regulatory delays, many analysts believe Acomplia can still produce annual sales of $1 billion or more. The drug is available in nine countries, mostly in Europe.
Sanofi-Aventis provided few details of the delay in its four-sentence press release Monday. The company said it had given the FDA results of a
recent clinical trial that indicated Acomplia improved blood-sugar control in diabetics for six months.
Earlier in the day, the FDA said the antibiotic Ketek, which the agency approved in 2004, will be banned for treating acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis.
Such an action isn't common, but in the case of Ketek, the move wasn't a surprise.
The FDA had come under criticism for its approval of the drug, and the government
conducted hearings on the matter. In December, an FDA advisory panel recommended that Ketek
be halted for these two uses, saying that the risks outweighed the benefits.
However, the advisory panel voted to keep Ketek as a treatment for community-acquired pneumonia, a common lung inflammation that affects people who aren't hospitalized or in long-term care facilities.
On Monday, the FDA said Ketek can still be used for mild to moderate pneumonia, but it said the label must warn that the drug shouldn't be used in patients with a muscle-weakness disease called myasthenia gravis. The label will contain a "black box" warning, the agency's strongest alert.
The Ketek label also will contain a stronger warning about the risk of visual problems and loss of consciousness.
In regular trading, shares of Sanofi-Aventis closed at $44.29, up 51 cents, or 1.2%, following a newspaper report that the company had
broken off merger talks with