These drugs were recently approved by the U.S. Food and Drug Administration (FDA):
• Vaccinia immune globulin intravenous (VIGIV) by DynPort Vaccine Co. LLC. The FDA has approved vaccinia immune globulin intravenous (VIGIV), the first intravenous human plasma-derived product available to treat certain rare complications of smallpox vaccination.
VIGIV is made from the pooled plasma of donors who received booster immunizations with the licensed smallpox vaccine — Dryvax. This plasma contains increased levels of protective antibodies against the vaccinia virus, the live virus used in the currently available smallpox vaccine. The vaccinia virus is similar to the smallpox virus, but does not cause smallpox.
Because the smallpox vaccine is made with this live virus, even though it is a weakened virus, occasionally it can cause infections in susceptible vaccinated people or those in close contact with them. People with weakened immune systems or certain skin conditions are susceptible to vaccine complications. VIGIV helps treat these complications.
The most common side effects from the smallpox vaccine such as a sore arm, fever, and body rashes, are self-limiting and do not require treatment. VIGIV would only be used for rare serious vaccine complications, such as a severe infection of the skin. Those at increased risk for these complications include people with eczema or other skin conditions, and people whose immune systems are suppressed due to diseases or medications, such as steroids or therapies for cancer.
The approval of VIGIV was based on both the safety of the product and prior evidence that the levels of protective antibodies achieved during treatment were adequate for treating complications of vaccination.
In clinical studies of VIGIV in 111 volunteers, the medicine was well-tolerated. When adverse effects were noted, they were mild to moderate and included headaches, hives, and other rashes.
• New indication for peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) by Roche. The FDA has approved peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) for the treatment of chronic hepatitis C in patients co-infected with hepatitis C (HCV) and HIV. Peginterferon alfa-2a was approved in 2002 by the FDA for use alone and in combination with ribavirin for the treatment of adults with chronic hepatitis C.
The FDA approval of the combination therapy for the treatment of HCV/HIV coinfected patients is based on results from APRICOT (AIDS Pegasys Ribavirin International Coinfection Trial), a study evaluating chronic hepatitis C treatment in patients coinfected with hepatitis C and HIV. The results showed that 40% of patients treated with peginterferon alfa-2a and ribavirin achieved a sustained virological response.
The adverse event profile of coinfected patients treated with peginterferon alfa-2a and ribavirin was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%), and mood alteration (9%).
• New indication for candesartan cilexetil (Atacand) by AstraZeneca. The FDA has approved the angiotensin receptor blocker (ARB) candesartan cilexetil (Atacand) tablets for the treatment of heart failure (NYHA class II-IV and ejection fraction less than or equal to 40%) to reduce the risk of death from cardiovascular causes and reduce hospitalizations for heart failure. Candesartan cilexetil is the first ARB to receive an indication for reducing both cardiovascular mortality and hospitalizations for heart failure.
The approval was primarily based on results from Candesartan in Heart Failure Assessment of Reduction in Mortality and morbidity Alternative Trial (CHARM-Alternative), which examined the effect of candesartan cilexetil (n = 1,013) compared to placebo (n = 1,015) in 2,028 heart failure patients who were intolerant to angiotensin-converting enzyme (ACE) inhibitors, but were receiving other standard heart failure therapy. The trial demonstrated that in these congestive heart failure patients, the use of candesartan cilexetil resulted in a 23% relative risk reduction in cardiovascular death or heart failure hospitalization (406 events in the placebo arm compared to 334 events in the patients receiving candesartan cilexetil), with both components contributing to this effect.
This finding was supported by a second study of 2,548 subjects (CHARM-Added) with NYHA Class II-IV heart failure and ejection fraction less than or equal to 40%, in which subjects were mostly on submaximal doses of ACE inhibitors. Together, in these studies, patients on ATACAND had a 15% lower risk of cardiovascular mortality. In these studies, symptoms of heart failure as assessed by NYHA functional class also were improved.
The recommended initial dose of candesartan cilexetil for the treatment of heart failure is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately two-week intervals, as tolerated by the patient. In the CHARM program, 21% of patients receiving candesartan cilexetil discontinued for adverse events vs. 16.1% of placebo patients.
These drugs were recently approved by the U.S. Food and Drug Administration (FDA): Vaccinia immune globulin intravenous (VIGIV) by DynPort Vaccine Co. LLC. The FDA has approved vaccinia immune globulin intravenous (VIGIV), the first intravenous human plasma-derived product available to treat certain rare complications of smallpox vaccination.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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