New FDA Approvals
These drugs were recently approved by the FDA:
• Combination measles, mumps, and rubella virus vaccine live (M-M-R II) and varicella virus vaccine live (Varivax) — called ProQuad — by Merck. The FDA has approved an attenuated live virus vaccine that is the combination of measles, mumps, and rubella virus vaccine live (M-M-R II) and varicella virus vaccine live (Varivax). The combination vaccine, called ProQuad, is approved for simultaneous vaccination against measles, mumps, rubella, and chickenpox in children 12 months to 12 years of age. It is the only vaccine approved in the United States that helps protect against the four diseases in a single shot.
The combination vaccine also is approved for use in children 12 months to 12 years of age if a second dose of measles, mumps, and rubella vaccine is to be administered. At least one month should elapse, however, between a dose of a measles-containing vaccine, such as M-M-R II, and a dose of ProQuad. If a second dose of varicella-containing vaccine is required, at least three months should elapse between administration of the two doses.
Merck says ProQuad provides immunogenicity and safety similar to its component vaccines, and has demonstrated antibody persistence at one year. No clinical data are available on the safety, immunogenicity, and efficacy of the combination vaccine in children younger than 12 months of age.
The company says the catalog price for the combination drug is $114.61 per dose purchased as a pack of 10 single-dose vials of lyophilized vaccine with sterile diluent water or $120.25 if purchased as an individual single-dose vial of lyophilized vaccine with sterile diluent water.
Merck has committed to a large-scale observational post-licensure safety study to evaluate the rate of febrile seizures in recipients of ProQuad in 25,000 subjects. According to FDA documents, the study will be initiated no later than January 2006 and will be completed by June 2008.
• Fluarix by GlaxoSmithKline. The FDA has approved Fluarix, an influenza vaccine for adults that contains inactivated virus. Fluarix is approved to immunize adults 18 years of age and older against influenza virus types A and B contained in the vaccine. The FDA says this approval is a big step toward providing an adequate supply of flu vaccine for the American public.
Fluarix is the first vaccine approved using FDA’s accelerated approval process. The agency says the manufacturer demonstrated that after vaccination with Fluarix adults made levels of protective antibodies in the blood that FDA believes are likely to be effective in preventing flu. GlaxoSmithKline will do further clinical studies as part of the accelerated approval process to verify the clinical benefit of the vaccine.
FDA based the accelerated approval of Fluarix on thorough evaluation of safety and effectiveness data from four clinical studies involving approximately 1,200 adults. Other data from post-marketing reports in other countries where Fluarix is already approved were also reviewed as part of FDA’s safety assessment.
• New indication for perindopril erbumine (Aceon) by Solvay Pharmaceuticals. The FDA has approved perindopril erbumine (Aceon) tablets for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction (MI). Prior to this labeling expansion, perindopril erbumine, an angiotensin-converting enzyme (ACE) inhibitor, was indicated for the treatment of essential hypertension.
The new indication is based on the EUROPA (EUropean trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease) study. EUROPA was a multicenter, randomized, double-blind, placebo-controlled trial in 12,218 patients with stable coronary disease and without heart failure, which assessed the ability of perindopril to reduce cardiovascular death, nonfatal MI, or cardiac arrest. Patients had a mean follow-up of 4.2 years.
In this study, in a broad population of patients with stable coronary artery disease, there was a 20% reduction in the combined endpoint of cardiovascular mortality, nonfatal MI, and cardiac arrest compared to placebo. This significant reduction in relative risk was seen in patients on a treatment regimen of 8 mg perindopril, including patients treated with conventional cardiovascular preventive therapy, such as aspirin, other anticoagulants, beta-blockers, and other antihypertensive therapy and lipid-lowering therapy, such as statins. Patients not randomized to receive perindopril received placebo in addition to their conventional therapy.
Perindopril erbumine is contraindicated in patients known to be hypersensitive to this product or to any other ACE inhibitors and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.
• Combination of pioglitazone HCl (Actos) and metformin (ACTOplus met) by Takeda Pharmaceuticals North America. The FDA has approved ACTOplus met for the treatment of Type 2 diabetes. ACTOplus met combines pioglitazone HCl (Actos) and metformin, two diabetes medications, in a single tablet.
The pioglitazone HCl/metformin combination will be available in two dosages — 15 mg/500 mg and 15 mg/850 mg — both of which are to be given once a day or in divided doses not exceeding the maximum recommended daily doses of pioglitazone 45 mg and metformin 2,550 mg as mentioned in the approved labeling.
Takeda expects the medication to be available to patients this month.
Combination measles, mumps, and rubella virus vaccine live (M-M-R II) and varicella virus vaccine live (Varivax) called ProQuad by Merck. The FDA has approved an attenuated live virus vaccine that is the combination of measles, mumps, and rubella virus vaccine live (M-M-R II) and varicella virus vaccine live (Varivax).Subscribe Now for Access
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