The Food and Drug Administration (FDA) has approved Northera, a new drug for the treatment of neurogenic orthostatic hypotension (NOH), a condition associated with Parkinson’s disease, multiple-system atrophy, and pure autonomic failure.
NOH, a sudden drop in blood pressure, can trigger fits of dizziness, blurred vision, and fainting. It can result in severely limiting a person’s ability to perform routine, daily activities and can lead to falls and injuries. PAN attended an FDA advisory committee meeting in January where the drug was recommended for approval. PAN also provided comments urging FDA to give serious consideration to the significantly debilitating nature of NOH and this current unmet medical need in treating Parkinson’s.
Northera was developed by Chelsea Therapeutics, a biopharmaceutical development company that develops products for the treatment of a variety of diseases, including central nervous system disorders. According to a FDA press release, the FDA approved Northera under the accelerated approval program, which allows for approval of a drug to treat a serious disease based on clinical data showing that the drug has an effect on an intermediate clinical measure (in this case, short-term relief of dizziness) that is reasonably likely to predict the outcome of ultimate interest (relief of dizziness during chronic treatment). This program provides patient access to promising drugs while the company conducts post-approval clinical trials to verify the drug’s clinical benefit, which for this approval is a long-term effect on patient symptoms in NOH, a chronic disease.
To learn more, click here.