FDA Approves Northera
FDA Approves Northera to treat Neurogenic Orthostatic Hypotension
February 18, 2014 -- The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure.
Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.
“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” said Norman Stockbridge, M.D., Ph.D, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available.”
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.
Northera received orphan-product designation from the FDA because it is intended to treat a rare disease or condition.
Northera is made by Charlotte-based Chelsea Therapeutics Inc.
Posted: February 2014
- Chelsea Therapeutics Issues Statement Regarding Postponement of Northera NDA PDUFA Date - February 14, 2014
- FDA Advisory Panel Recommends Approval of Chelsea Therapeutics' Northera (Droxidopa) for the Treatment of Symptomatic nOH - January 14, 2014
- Chelsea Therapeutics Announces FDA Advisory Committee to Review Northera - October 9, 2013
- Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission - September 4, 2013
- Chelsea Therapeutics Announces Submission of Additional Information for Northera NDA - August 15, 2013
- Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission - July 17, 2013
- Chelsea Therapeutics Resubmits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH - July 9, 2013
- Chelsea Therapeutics Receives FDA Guidance for a Northera (Droxidopa) NDA Resubmission With Study 306B - February 20, 2013
- Chelsea Therapeutics Provides an Update on Northera (droxidopa) Regulatory Status and Development Program - July 3, 2012
- Chelsea Therapeutics Completes End-of-Review Meeting With FDA for Northera (droxidopa) NDA - May 22, 2012
- Chelsea Therapeutics Receives Complete Response Letter from Food and Drug Administration for Northera (droxidopa) Capsules - March 28, 2012
- FDA Advisory Panel Recommends Approval of Chelsea's Northera (droxidopa) for the Treatment of Symptomatic Neurogenic OH - February 24, 2012
- Chelsea Therapeutics CEO to Review Northera NDA and Provide an Update on Upcoming Advisory Committee Meeting During Presentation at BIO CEO - February 14, 2012
- Chelsea Therapeutics Announces FDA Advisory Committee Meeting Date for Review of Northera NDA for the Treatment of Symptomatic NOH - January 5, 2012
- Chelsea Therapeutics Submits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH - September 28, 2011
- Chelsea Therapeutics Accelerates Northera NDA Filing Following Meeting With FDA - December 20, 2010
- Chelsea Therapeutics Announces Advancements in Neurogenic Orthostatic Hypotension Registration Program - February 9, 2010