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Charlotte's Chelsea Gets FDA OK for Northera

Charlotte biopharmaceutical company Chelsea Therapeutics hit paydirt today with the marketing approval from the U.S. Food and Drug Administration for NORTHERA, Chelsea’s first product.

NORTHERA is a treatment for a sudden drop in blood pressure that occurs while standing. The disorder is technically known as symptomatic neurogenic orthostatic hypotension (NOH).

“The approval of NORTHERA is an extraordinary achievement,” said Joseph Oliveto, Chelsea president and CEO, “one for which I thank patients and their families, investigators and the medical community, our partner Dainippon Sumitomo, and our employees.

“We will now turn our efforts towards delivering NORTHERA to patients with NOH in the United States, an important goal we expect to achieve in the second half of the year.”

Chelsea licensed the compound in NORTHERA, also called droxidopa, from Japanese drug company Sumitomo Pharma. The small Charlotte firm encountered numerous twists and turns in its efforts to get the drug to market, including earlier rebuffs from the FDA, corporate leadership changes, employee cutbacks and ultimately, approval of orphan and fast-track status for NORTHERA.

Chelsea had originally set out to market the drug for treating dizziness and fainting in Parkinson’s disease patients.

Under the FDA approval, NORTHERA will contain a boxed warning to alert doctors and patients about potential risks, and the package insert must indicate that the drug hasn’t yet been proven effective if taken for more than two weeks. But significantly for Chelsea, the FDA put no restriction on prescription use of the drug.

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