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Weekly Drug News Round Up - February 19, 2014

Northera FDA-Approved for Neurogenic Orthostatic Hypotension

Northera is an orally active synthetic precursor of norepinephrine for the treatment of neurogenic orthostatic hypotension Read More...

The U.S. Food and Drug Administration (FDA) has approved Chelsea Therapeutic’s Northera (droxidopa) capsules for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare and often disabling drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. This severe drop in blood pressure can often limit the ability to complete daily activities that require walking or standing. Northera has a boxed warning about the risk of increased blood pressure while lying down. Patients must keep their head and upper body elevated when sleeping and lying down, and blood pressure should be monitored.

Vimizim Approved for Rare Morquio A Syndrome

Vimizim is the first drug to receive the Rare Pediatric Disease Priority Review Voucher to encourage development of new agent for rare pediatric diseases Read More...

The U.S. Food and Drug Administration has approved BioMarin Pharmaceutical’s Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Mucopolysaccharidosis Type IVA is a rare lysosomal storage disease that can lead to problems with bone development, growth and mobility. Vimizin replaces a necessary enzyme called N-acetylgalactosamine-6-sulfate sulfatase (GALNS). Clinical trials with Vimizim involved 176 participants ranging in age from 5 to 57 years. On average, patients treated with Vimizim walked 22.5 meters farther in 6 minutes compared to the patients who received placebo. The most common side effects included fever, vomiting, headache, nausea, abdominal pain, chills and fatigue.

FDA Begins Pilot Program to Increase Security of Imported Drugs

In the program, 13 prequalified pharmaceutical companies, including AbbVie, GSK, Pfizer and Teva, were accepted for participation Read More...

The U.S. Food and Drug Administration (FDA) is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. The goal of the program is to enable the FDA to encourage manufacturers to adopt best practices for supply chain integrity, thus allowing FDA to focus their resources on areas with the greatest potential risk to consumers. This will help to prevent the entry of high-risk imported drugs that are the most likely to compromise the quality and safety of the U.S. drug supply. If the FDA determines the program to be effective, a more permanent program may be established.

Antidepressant Celexa May Help Ease Agitation in Dementia Patients: Study

Celexa may offer a safer alternative to antipsychotic drugs; antipsychotic drugs are associated with a higher risk of death for Alzheimer's patients Read More...

The antidepressant Celexa (available generically as citalopram) shows promise in easing the agitation people with Alzheimer's disease often suffer. Agitation can be a disabling condition, leading to physical and mental exhaustion for patients and caregivers, as well as putting the patient at higher risk for other comorbidities like infections or heart stress. In a 9-week placebo controlled study, patients took either Celexa or placebo. Patients taking the drug showed a significant decline in their agitation symptoms and caregivers reported less stress. Celexa can be associated with its own set of side effects, but they may be less severe than those of antipsychotics. Use should be determined case-by-case in conjunction with patient, family and physician.

Early Clot-Busting Treatment Helps Most Stroke Patients: Study

A new study finds that tPA reduces the risk of long-term disability and that earlier treatment improved outcomes Read More…

Guidelines recommend and recent studies have shown that quick treatment with clot-busting drugs like tissue plasminogen activator (tPA) can limit brain damage in stroke patients. However, there is ongoing debate about when to give it and if it’s safe in older patients. A team of British experts reviewed data from more than 6,700 stroke patients who took part in nine clinical trials. The review showed that 33 percent of patients who were given tPA within three hours of the start of stroke symptoms did not have significant disability three to six months later, compared with 23 percent of those who did not receive the drug.