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Breaking Regulatory News: FDA Panel Unexpectedly Recommends Approval for Parkinson's Disease Neurogenic Orthostatic Hypotension Drug

Never a dull moment in the world of drug development, clinical trials and regulatory approval. Yesterday an FDA advisory committee recommended that FDA approve Northera, the Charlotte, North Carolina-based biotech Chelsea Therapeutics' potential new drug for orthostatic hypotension in multiple disorders, including Parkinson's. This could be great news for Parkinson's patients, but it was entirely unexpected, since Chelsea had voluntarily released news of safety concerns about the drug two days ealier (by the way, a highly unusual move). The company lost a third of its market value in the wake of that first announcement, value that has now been regained (and then some) as its stock soars on the strength of the unexpected good news.

So what explains the reversal of fortune? Hard to know, but Michael J. Fox Foundation (MJFF) CEO Todd Sherer speculates that the advisory committee may have been willing to tolerate a somewhat higher level of risk given that there is no available treatment for orthostatic hypotension in Parkinson's disease --  a sudden drop in blood pressure when a person stands up. It's common in Parkinson's, and can lead to falls and injury.

In related news, MJFF is funding a separate project on Northera investigating its potential to treat gait, sleep and cognitive disorders in Parkinson's disease under our Repositioning Existing Drugs program.

FDA advisory committees' recommendations are non-binding, but FDA does usually follow them. In Northera's case,  FDA is expected to rule on March 28. Watch this space for updates.

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