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Weekly Drug News Round-Up: December 28, 2016

Biogen’s Spinraza Approved for Spinal Muscular Atrophy

Spinraza is an injection administered into the fluid surrounding the spinal cord Read More...

The U.S. Food and Drug Administration (FDA) has cleared Biogen's Spinraza (nusinersen), the first drug for spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is classified as a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide and alters the splicing of the SMN2 gene to yield a more functional protein. In an interim analysis of efficacy, 40% of patients treated with Spinraza achieved improvement in defined motor milestones such as sitting, standing and walking, while no control patients meet milestones. Common side effects reported are respiratory infection and constipation; warnings include low blood platelet counts and kidney toxicity.

Ocrevus Deemed A “Breakthrough” for Primary Progressive Multiple Sclerosis

Multiple Sclerosis (MS) is a nervous system disorder with symptoms of visual difficulties, muscle weakness, and fatigue Read More...

Ocrelizumab (RG1594, Ocrevus) from Genentech/Roche is awaiting approval by the FDA for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis. Ocrevus had been set for FDA final review this month, but is now extended into March. Two studies confirm the significant impact this investigational drug could have on MS, including primary progressive MS which has no approved treatment. Ocrelizumab reduced the advance of MS-related disability by 24 percent in people with primary progressive MS compared to a placebo. Researchers also noted that new areas of inflammation in the brain were reduced by 95 percent.

More Evidence: Antipsychotic Drugs Up Early Death in Alzheimer's Patients

Antipsychotics already include this boxed warning, FDA’s strongest safety labeling Read More...

The first warnings about increased risk of death among elderly Alzheimer's patients taking antipsychotics were issued more than 10 years ago. Antipsychotics include drugs such as aripiprazole, quetiapine, and risperidone. New research published in the Journal of Alzheimer's Disease now adds to the evidence that antipsychotic use in patients with Alzheimer’s disease can hasten death. The study found a 60 percent higher risk of death in those using antipsychotics compared to those who didn't take the drugs. Patients who took two or more antipsychotic drugs at the same time, instead of one, were nearly twice as likely to die early.

Ebola Vaccine: Regulatory Submission Not Far Off

The 2014 Ebola outbreak in West Africa killed more than 11,000 people Read More...

A study published this week in The Lancet reports on a new investigational Ebola virus vaccine called rVSV-ZEBOV. The 2015 vaccine trial included nearly 12,000 people, and was conducted by the World Health Organization (WHO), Guinea's Ministry of Health and international partners. Among 5,800 people who received the vaccine, no Ebola cases were recorded 10 days or more after vaccination; however, 23 cases developed among those who did not get vaccinated. Further safety studies in pediatric and HIV patients are needed. Merck will submit the vaccine for FDA approval by the end of 2017, but will make 300,000 doses available for emergency use in the interim.

Diabetes: Where Health Care Spending Hits Hardest

Healthcare spending and drug costs continue to be major and controversial themes Read More...

A new report, published this week in the Journal of the American Medical Association (JAMA), showed that U.S. spending on diabetes diagnosis and treatment totaled over $100 billion in 2013 and has grown 36 times faster than spending on heart disease, the nation’s #1 killer. In fact, healthcare spending on diabetes grows an amazing 6 percent each year. The top 5 most costly health expenses in 2013, according to the analysis, were: diabetes at $101.4 billion, ischemic heart disease at $88.1 billion, low back and neck pain at $87.6 billion, high blood pressure at $83.9 billion, and injuries from falls at $76.3 billion.