US Approval For Knoll's Obesity Drug Meridia

BASF subsidiary Knoll has been granted marketing approval in the USA forMeridia (sibutramine), its new centrally-acting drug for the management of obesity, pending an appraisal by the Drug Enforcement Agency. This is the second approval for the drug. It was first cleared in Mexico in mid-November, but Knoll says the USA will be the debut market for the product.

Knoll is determined to distance itself from the problems seen with other centrally-acting anorectics, including phentermine and fenfluramine/dexfenfluramine, which have been taken off the market following links to serious heart valve disorders (Marketletters passim). It says that sibutramine has a different mode of action, inhibiting the reuptake of serotonin and noradrenaline but without stimulating their release.

Furthermore, the company has resolved to make sure that the drug is only used in the indicated population, ie those with a body mass index of 30 or more, or 27 or more if they have other risk factors such as hypertension and dyslipidemia. It has implemented a series of educational programs for physicians, medical boards and weight loss centers offering guidelines on the appropriate use of the drug.