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Chelsea’s Northera wins FDA approval in NOH; black-box warning

By Randy Osborne, Staff Writer

The long, hazard-fraught road for Chelsea Therapeutics International Ltd. with Northera (droxidopa) – including unfavorable briefing documents, followed by a positive advisory committee (adcom) vote – came to a happy end with approval of the drug by the FDA for neurogenic orthostatic hypotension (NOH), or a sudden drop in blood pressure when the patient stands up.

Ahead of the news Tuesday afternoon, Chelsea’s shares (NASDAQ:CHTP) halted trading at $4.95.

Northera bears a boxed warning about the risk of increased blood pressure while lying down. Patients are directed to sleep with their head and upper body elevated. Supine blood pressure should be monitored before and during treatment and more frequently when increasing doses, the warning says.

In January, an FDA panel voted 16-1 in favor of the approval of Charlotte, N.C.-based Chelsea’s orally active synthetic precursor of norepinephrine, though the panel was first skeptical, as was the agency itself, with regard to the durability of positive data gleaned from shorter-term studies. (See BioWorld Today, Jan. 13, 2014.)

It’s almost a reversal of what happened two years ago, when negative briefing documents appeared ahead of Northera’s first adcom, followed by a positive panel vote, followed by – instead of approval – a complete response letter from the unconvinced FDA, which wanted more trial data. (See BioWorld Today, Feb. 14, 2012, Feb. 24, 2012, and March 30, 2012.)

Deutsche Bank analyst Alethia Young predicted Northera could sell as much as $550 million worldwide, with $450 million of that in the U.S.