FDA Approvals: Fluarix, Increlex, and ACTOplus met

Yael Waknine

September 01, 2005

Sept. 1, 2005 — The U.S. Food and Drug Administration (FDA) has approved a trivalent inactivated split influenza vaccine for the prophylaxis of influenza types A and B in adults; mecasermin [rDNA origin] injection for the long-term treatment of growth failure in children with severe primary insulin grown factor 1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH; pioglitazone HCl plus metformin HCl tablets for the management of type 2 diabetes.

Influenza Vaccine (Fluarix) in Preparation for 2005-2006 Influenza Season

On Aug. 31, the FDA approved a trivalent inactivated split influenza vaccine (Fluarix, made by Sächsisches Serumwerk, a German subsidiary of GlaxoSmithKline [GSK] Biologicals, and distributed by GSK) for the prophylaxis of influenza types A and B in adults, especially those at increased risk of associated complications.

The accelerated approval was based on an analysis of data from four clinical studies in approximately 1,200 adults, showing the vaccine to be safe and immunogenic. Postmarketing reports from other countries in which the product is already approved were also included in the assessment.

Adverse events were generally mild and self-limited in nature; injection site pain, muscle aches, fatigue, and headache were most commonly reported.

As a condition of approval, the company will be conducting additional studies to verify the clinical benefit of the vaccine.

The product was previously granted investigational new drug status by the FDA in December 2004. It was originally approved in 1992 for use outside of the U.S. in individuals aged six months and older and is currently distributed in 79 countries worldwide.

Mecasermin Injection (Increlex) for Severe Primary IGF-1 Deficiency in Children

On Aug. 30, the FDA approved mecasermin [rDNA origin] injection (Increlex, made by Tercica, Inc.) for the long-term treatment of growth failure in children with severe primary insulin growth factor 1 (IGF) deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

The approval was based on a six-month priority review of data from five clinical trials in 71 pediatric patients, showing that mecasermin therapy yielded a significant increase in growth during an eight-year period (P < .001). Compared with pretreatment growth patterns, children gained an additional inch of height during each year of treatment.

Mecasermin was generally well tolerated; adverse events were mild to moderate in severity and most commonly included hypoglycemia, lipohypertrophy, and tonsillar hypertrophy.

The recommended starting dose for mecasermin is 40 to 80 µg/kg twice daily by subcutaneous injection, administered within 20 minutes of a meal or snack. If well tolerated for at least one week, the dose may be increased by 40 µg/kg/dose to a maximum of 120 µg/kg given twice daily.

The FDA notes that preprandial glucose monitoring should be considered at treatment initiation until a well-tolerated dose is established; continued monitoring is recommended in patients who exhibit frequent symptoms of hypoglycemia. Discontinuation of therapy is advised in patients experiencing hypoglycemia at recommended doses of mecasermin despite adequate food intake.

Pioglitazone Plus Metformin Tablets (ACTOplus met) for Type 2 Diabetes

On Aug. 29, the FDA approved pioglitazone HCl plus metformin HCl tablets (ACTOplus met, made by Takeda Pharmaceuticals North America, Inc.) for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already receiving combination therapy with the individual components or whose diabetes is not adequately controlled by use of either drug alone.

The approval was based on data demonstrating the product's bioequivalence to coadministered pioglitazone and metformin tablets, which were previously shown in clinical studies to be safe and effective together for the management of type 2 diabetes.

The 15/500-mg and 15/850-mg pioglitazone/metformin tablets are administered once a day or in divided doses not to exceed the maximum recommended daily doses of 45 mg and 2,550 mg, respectively.

Reviewed by Gary D. Vogin, MD

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