Northera, the Chelsea Therapeutics (NASDAQ:CHTP) drug developed to treat dizziness and fainting experienced by Parkinson’s disease patients, has the nod for approval from an advisory committee to the U.S. Food and Drug Administration.
The 7-4 vote with one abstention and one “non-vote” from the independent panel does not bind the FDA to rule one way or another on the drug. But the vote of confidence in the compound does run counter to the conclusion of the FDA’s own staffers, who were concerned about Northera’s short duration and possible safety issues that arose during clinical trials. The FDA staff review recommended against approving Northera.
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Charlotte, North Carolina-based Chelsea licensed the compound droxidopa from Japanese drug company Sumitomo Pharma. Droxidopa has been used in Japan since 1989. Chelsea developed the compound, which it calls Northera, to treat a condition called neurogenic orthostatic hypotension, or NOH. The sudden drop in blood pressure from the condition can cause dizziness and fainting in Parkinson’s patients. NOH treatments that are available carry serious health risks, so the FDA granted Northera orphan drug status and priority review based on its potential to address an unmet medical need. With the priority review, an FDA decision on the drug could come by March 28.
Priority review is intended to speed the regulatory process for drugs addressing conditions that lack treatments options. But in a Thursday evening conference call to discuss the day-long meeting with the FDA panel, Chelsea CEO Simon Pedder suggested that the priority review might have worked against Northera, at least in one respect.
“If there is a negative about getting an expedited review, there’s a limited amount of time to review and get questions back to the sponsor,” Pedder said.
While the FDA staff raised safety concerns about Northera — at least 19 deaths were reported in clinical trials — staffers also acknowledged that a statistically significant number of patients did benefit from treatment. The independent advisory panel possibly saw Northera’s benefit outweighing its risks, particularly in light of the few treatment options available for NOH.
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Chief medical officer Bill Schweiterman said until the targeted action date on the drug, he expects Chelsea will have back-and-forth discussions on the path forward. Pedder said that Chelsea would be open to conducting additional post-marketing studies to collect more data on patients using Northera.
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