Updated from 4:45 pm ET with additional information, including CEO comments.
The FDA has approved Chelsea Therapeutics' (CHTP) Northera for the treatment of neurogenic orthostatic hypotension (NOH), a rare disease which causes a debilitating drop in blood pressure upon standing.
Here's a snippet from the FDA announcement:
The FDA is approving 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.
Northera has a boxed warning to alert health care professionals and patients about the risk of increased blood pressure while lying down (supine hypertension), a common problem that affects people with primary autonomic failure and can cause stroke. It is essential that patients be reminded that they must sleep with their head and upper body elevated. Supine blood pressure should be monitored prior to and during treatment and more frequently when increasing doses.
The most common adverse events reported by clinical trial participants taking Northera were headache, dizziness, nausea, high blood pressure (hypertension) and fatigue.
The effectiveness of Northera was shown through two-weeks in two clinical trials in people with NOH. People taking Northera reported a decrease in dizziness, lightheadedness, feeling faint, or feeling as if they might black out compared to those taking an inactive pill (placebo). Durability of the improvement in patient symptoms beyond two weeks has not been demonstrated.
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