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Weekly Drug News Round Up - November 19, 2014

Genzyme’s Lemtrada Wins Approvals for Relapsing Multiple Sclerosis

Lemtrada should generally be reserved for patients who have had an inadequate response to two or more MS drugs Read More...

Over 400,000 people are living with MS in America. The U.S. Food and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms (flare-ups) of multiple sclerosis (MS) that lead to worsening neurologic function. Lemtrada has a unique dosing and administration schedule of two annual treatment courses. However, Lemtrada contains a boxed warning for serious, sometimes fatal autoimmune conditions, serious infusion reactions, and increased risk of malignancies and must be accessed via a restricted program. Genzyme also received FDA approval of its once-daily, oral Aubagio (teriflunomide) for the treatment of relapsing forms of MS in September 2012.

FDA: The Dual Antiplatelet Therapy (DAPT) Trial

Patients should NOT stop these drugs due to an increased risk of heart problems Read More...

Clopidogrel (Plavix) and prasugrel (Effient) are important medicines used to prevent heart attacks, strokes, and other clot-related diseases. The Dual Antiplatelet Therapy (DAPT) trial, published in the New England Journal of Medicine on November 16 shows that treatment with aspirin plus either clopidogrel or prasugrel for 30 months decreased the risk of heart attacks and clot formation in cardiac stents. However, there was an increased overall risk of non-cardiovascular death at 30 months compared to a shorter treatment period of 12 months. FDA has not reached any conclusions based on the findings from this clinical trial, but will communicate when evaluation is complete. An investigator review states the increased death rates in the DAPT study are due to a previous diagnosis of cancer in one randomized group.

Invega Sustenna Receives Priority Approval for Schizoaffective Disorder

Symptoms of schizoaffective disorder are complex and, without treatment, disabling Read More…

Janssen’s Invega (paliperidone) Sustenna is the first FDA-approved once-monthly medication to treat schizoaffective disorder alone or with other drugs. Schizoaffective disorder is a mental illness with an overlap of psychotic and mood symptoms like delusions, hallucinations, depression and mania. A 15-month study measuring ability to delay relapse in schizoaffective disorder found that treatment resulted in a statistically significant delay in relapse compared to placebo. Common side effects with Invega Sustenna, defined by at least a 5% incidence and twice that of placebo, include injection site reactions, sleepiness, dizziness, and movement disorders.

Generics More Affordable? Not Always, According to Recent Trends

Government regulators have undertaken investigations into generic drug pricing Read More...

As published last week in the New England Journal of Medicine, generic drug prices are skyrocketing. Generic drugs are supposed to be a cost-saving tool for American health care consumers, but this report suggest otherwise for some drugs. For example, doxycycline, an antibiotic often prescribed in cases of Lyme disease, has increased from 6.3 cents per capsule to about $3.36, and clomipramine, used in obsessive-compulsive disorder, has climbed from 22 cents to 8.32 per pill. Drug shortages, lack of manufacturers that make specific generics, and the resultant monopoly market seem to blame.

Sanofi and Regeneron's Cholesterol Drug Shows Promise

Alirocumab improves the removal of LDL (“bad”) cholesterol from the bloodstream by blocking a protein Read More...

Many patients cannot tolerate the cholesterol lowering drugs called “statins” due to muscle pain side effects. Statins work by block cholesterol production by the liver. Oral ezetimibe (Zetia), which lowers cholesterol absorption, has often been the alternative for these patients. An experimental drug to lower cholesterol by the name of alirocumab - not in either class - is showing promise as a possible alternative to manage muscle side effects. A drawback - alirocumab requires an injection every two weeks, while statins and Zetia are taken daily by mouth.