Cath Lab Digest

New Drug for Rheumatoid Arthritis
The FDA has approved tocilizumab (Actemra) for the treatment of adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis. Recommendations for the use of tocilizumab is limited to patients who have failed other approved therapies because of serious safety concerns that were noted in clinical studies. These safety concerns include elevated liver enzymes, elevated low-density lipoprotein (LDL) or bad cholesterol, hypertension, and gastrointestinal perforations.

Tocilizumab works by blocking the action of interleukin-6, an immune system protein that is overabundant in people with rheumatoid arthritis. The effectiveness and safety of tocilizumab was determined in 5 clinical trials in adult patients with active rheumatoid arthritis. In all of the trials, patients treated with tocilizumab experienced greater improvement in their tender or swollen joints than patients treated with a placebo.

The FDA is requiring the marketer, Genentech Inc, a subsidiary of the Roche Group, to conduct a postmarketing clinical trial to further evaluate the long-term safety of tocilizumab. Specifically, the FDA wants to evaluate the impact of elevated LDL cholesterol and blood pressure seen in some patients in shorter-term trials on the cardiovascular health of patients treated with tocilizumab.

In addition, a Risk Evaluation and Mitigation Strategy (REMS) will require the drug sponsor to implement a Communication Plan for physicians informing them how to appropriately monitor their patients for liver and/or gastrointestinal side effects. The REMS will include a Medication Guide to ensure that patients are informed of the benefits and risks of tocilizumab.

High-dose Flu Vaccine
Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B, was approved by the FDA on December 23. The high-dose vaccine is intended specifically for patients age 65 and older. People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older, and the product was approved under the FDA’s accelerated process for vaccine approval.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA’s accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

Fluzone High-Dose, manufactured by Sanofi Pasteur Inc, is formulated so that each 0.5 mL dose contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA), which is made up of 60 mcg of each of the 3 influenza virus strains. As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 mcg of influenza virus hemagglutinin (15 mcg HA from each of the 3 influenza strains per dose). Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.

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