A weight-loss pill that blocks food craving signals in the brain can be approved if certain conditions are met, U.S. regulators said on Friday.
The U.S. Food and Drug Administration sent the French drug maker Sanofi-Aventis an “approvable” letter outlining what the company must do to get the drug on the market, an FDA spokeswoman said. The conditions were not disclosed.
Investors had been waiting to see if Acomplia, a potential blockbuster and key growth driver for Sanofi, would receive full FDA approval. The approvable letter means regulators need more time before giving final clearance.
Shares of Sanofi-Aventis fell 2.7 percent to $42.99 in after-hours trading on the Inet electronic brokerage, after closing at $44.20 earlier on the New York Stock Exchange.
Sanofi-Aventis representatives could not immediately be reached for comment.
Mehta Partners analyst Shaojing Tong said the approvable letter was “within expectations.”
“Given what management told people two weeks ago (at an analyst meeting), they are still confident they should be able to get final approval in the short term,” Tong said.
The conditions for approval “should be minor issues” because the company has been working closely with the FDA, he added.
Sanofi has forecast annual sales of about $3 billion for the drug, which works by blocking craving signals in the brain for food. Sanofi developed Acomplia based on the theory that marijuana users often experience intense hunger, and blocking those receptors in the brain should control appetite.
Two-thirds of Americans are classified as overweight or obese. A global obesity epidemic is threatening the health of millions of people in developed countries, who face an increased risk of heart disease, diabetes and certain cancers.
Clinical trials showed patients taking once-daily Acomplia lost weight, reduced their waist size and achieved higher levels of “good” HDL cholesterol, which can cut the risk of heart disease.
One study showed Acomplia helped patients shed three times as much weight as those on placebo. About 32 percent of the overweight and obese patients taking the drug in a clinical trial lost a tenth of their weight after two years compared with 11 percent of patients on placebo.
Side effects such as vomiting and nausea forced about 19 percent of patients to leave the trial versus 13 percent of those who took a placebo.
The drug, known by the generic name rimonabant, also has been shown to help people quit smoking.
Acomplia would compete with other weight-loss drugs such as Roche Holding AG’s Xenical and Abbott Laboratories Inc’s Meridia.
Xenical works by preventing fat from being absorbed by the body, a process that can cause oily stools, excess gas and rectal discharge.
The FDA is considering GlaxoSmithKline Plc’s application to sell a nonprescription, low-dose version of Xenical under the name Alli.
Abbott’s Meridia is an appetite suppressant. Its side effects range from headaches and constipation to higher blood pressure and a faster heart rate.
