US regulators have approved Chelsea Therapeutics’ Northera as a treatment for a rare blood pressure condition associated with neurological conditions.
The Food and Drug Administration (FDA) backed Northera capsules (droxidopa) to treat neurogenic orthostatic hypotension (NOH), a chronic drop in blood pressure that is found in patients with Parkinson’s disease, multiple-system atrophy and pure autonomic failure.
The approval follows a near unanimous recommendation from the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) last month, although final approval was delayed last week after severe weather conditions on the US east coast forced FDA offices to close.
The orphan drug Northera is now the first FDA-backed treatment for the condition, which leads to severe dizziness and lightheadness and is thought to affect between 80,000 and 150,000 patients in the US.
The drug’s filing was expedited under the FDA’ accelerated approval programme, which allows new treatments for serious diseases to be approved more quickly if clinical trials have demonstrated the drug’s potential.
Chelsea achieved this by showing the drug’s short-term effectiveness, with patients reporting a decrease in dizziness and other symptoms after just two weeks of treatment.
However, as per all accelerated approvals, Chelsea will have to conduct post-approval clinical trials to verify the drug’s clinical benefit. In this case, Chelsea will have to show that Northera has a long-term effect on symptoms of NOH, not just the short-term effect that current data supports.
Dr Norman Stockbridge of the FDA’s Center for Drug Evaluation and Research, commented on the need for treatments in NOH.
“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” he said.
“There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available.”
Northera’s active ingredient droxidopa was initially developed by Japanese firm Dainippon Sumitomo Pharma and has been available in the company’s home nation since 1989.
