News Feature | January 22, 2014

FDA Advisory Panel Votes For Northera For A Second Time

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By Cassandra Leger

This week, an FDA advisory panel voted 16-1 in favor of Northera, a drug manufactured by Chelsea Therapeutics and used to treat Neurogenic Orthostatic Hypotension NOH - a rare form of low blood pressure. The disease is associated with neurological disorders including Parkinson’s disease and affects the patient only when they are in a standing position.

After ingested, the drug is transformed into norepinephrine, a chemical that communicates with the heart and blood vessels instructing them to regulate the blood pressure. When this chemical is absent from the body people will experience headaches and feel faint whenever they stand.

According to the panelists, the strongest argument they battled during voting was the fact that clinical trials associated with Northera were lacking data. While the drug is presented as being effective during the course of a one week treatment, there was no data suggesting it would be effective during a long term treatment. Thus, the advisory panel did advise the FDA that the drug maker should conduct follow up studies to strengthen the data behind the drug’s benefits.

Chelsea Therapeutics initially presented the drug to the FDA with a request for approval in 2011. The advisory panel voted for approval of the drug in 2012; however the FDA rejected the request stating that more documentation was needed. Chelsea Therapeutics then tried to recover their standing by providing additional documentation generated by study number 306B; however, the FDA ruled an additional trial would have to be conducted to satisfy the need for documented proof of the drug. After an appeal in 2013, the FDA agreed to accept a resubmission with supporting data from 306B.

Dr. Vasilios Papademetriou, cardiologist and professor of medicine at Georgetown University, stated "This is a terrible disease and there are no other effective medications. Although the studies were not perfect, the data convinced me there is a long lasting benefit in some patients."

Sources:

http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/cardiovascularandrenaldrugsadvisorycommittee/ucm381155.pdf

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