Chelsea Therapeutics Drug Shouldn’t Be Approved, FDA Says

Chelsea Therapeutics International Ltd.’s drug to treat a condition that can cause dizziness in people with nervous system disorders may be unsafe and shouldn’t be approved, U.S. regulators said. The company’s shares fell. 

The medicine, called Northera, lacks adequate data it works, Food and Drug Administration staff said today in a report. Agency advisers are set to meet Feb. 23 on whether the agency should approved the drug, chemically known as droxidopa. If so, it would be the first product marketed by the Charlotte, North Carolina-based company. 

The FDA had previously expressed concern about the length of trials and reports of a life-threatening neurological disorder that may be linked to the drug, Chief Executive Officer Simon Pedder said in a Feb. 13 statement. Northera would treat a condition that causes blood pressure to drop within three minutes of standing up, Chelsea Therapeutics said. 

“On the basis of the safety concerns compounded by absence of evidence of durability of effect,” the drug shouldn’t be approved at this time, the report said.

Source: Bloomberg Businessweek