FDA Drug and Device Approvals: July 1, 2004

Yael Waknine

July 01, 2004

July 1, 2004 — The U.S. Food and Drug Administration (FDA) has approved leeches as a device for skin grafts and reattachment surgery, an oral HIV-2 antibody test with results in 20 minutes, generic dimenhydrinate injection for motion sickness, and a new device for the treatment of heart failure. The European Commission has granted the CE mark of approval for cetuximab in the treatment of metastatic colorectal cancer in the European Union (EU).

Leeches for Skin Grafts and Reattachment Surgery

On June 28, the FDA cleared the commercial marketing of leeches for medicinal purposes by Ricarimpex SAS, a French firm that has been breeding the leeches in a certified facility for 150 years. According to the FDA, leeches meet the definition of a medical device under the Food, Drug, and Cosmetic Act.

The small, bloodsucking aquatic worms can be used to remove pooled blood from under a skin graft to help it heal and from blocked veins to restore circulation. Leeches also can be used in reattachment surgery for body parts such as fingers or ears.

The FDA based its approval on an evaluation of published literature on the use of leeches in medicine, safety information provided by the company, and a review of the breeding environment.

OraQuick Rapid HIV-1/2 Antibody Test Detects HIV-2 in Oral Fluid Samples

On June 23, the FDA approved a new indication for the OraQuick Rapid HIV-1/2 Antibody Test (made by OraSure Technologies Inc.), allowing its use in detecting antibodies to human immunodeficiency virus type 2 (HIV-2) in oral fluid samples. The point-of-care test is now approved for use in detecting antibodies to both HIV-1 and HIV-2 in oral fluid, finger stick and venous whole blood, and plasma samples. Results are available in 20 minutes.

On June 25, the FDA approved a waiver through its Center for Devices and Radiological Health under the Clinical Laboratory Improvements Amendments of 1988 (CLIA) for the antibody test, allowing its use in more than 180,000 sites in the U.S., including outreach clinics, community-based organizations, and physicians' offices.

Generic Dimenhydrinate Injection USP for Motion Sickness

The FDA approved on June 24 a new generic of dimenhydrinate (dimenhydrinate injection USP, made by American Pharmaceutical Partners, Inc.), an antiemetic indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness. It is the generic equivalent of Dramamine (made by Pfizer) and will be available in 50 mg/mL, 1 mL vials.

Manufacturing of dimenhydrinate injection had been discontinued since 2000 for reasons other than safety or efficacy.

Cardiac Device (InSync Maximo CRT Defibrillator System) for Heart Failure

On June 28 the FDA approved the InSync Maximo cardiac resynchronization therapy (CRT) defibrillator system (made by Medtronic, Inc.) for the treatment of heart failure. The device has the capacity to deliver high-output defibrillation energy (35 joules) to stop an abnormally fast hearth rhythm with "the industry's fastest charge times," according to a Medtronic news release. Charge time refers to the number of seconds between detection of the abnormal rhythm and the release of energy for defibrillation.

The InSync Maximo also includes antitachycardia pacing (ATP) options for painlessly terminating ventricular tachyarrhythmias, reducing the number of shocks to a patient by as much as 77%.

EU Approves Cetuximab (Erbitux) for Metastatic Colorectal Cancer

On June 30, the European Commission granted European Union marketing approval for cetuximab (Erbitux, made by Merck KgaA), indicated for use in combination with irinotecan for the treatment of epidermal growth factor receptor–expressing metastatic colorectal cancer after failureof irinotecan-based cytotoxic therapy.

The approval was based on results from the Bowel Oncology and Cetuximab Antibody (BOND) study showing that cetuximab used in combination with irinotecan shrank tumors by more than half in 23% of patients and stopped tumor growth in 33% of patients.

Cetuximab is well tolerated and does not increase the typical adverse effects of irinotecan. The most commonly reported adverse effect is an acne-like skin rash that occurs in more than half of all patients but rarely leads to dose reductions or termination of therapy. The rash is reversible after completion of therapy and may also be associated with a good response to therapy.

Cetuximab (made by ImClone in the U.S.) has been on the market in the U.S. since its FDA approval on Feb. 12. It has also been approved in Switzerland, Argentina, Chile, and Mexico.

Reviewed by Gary D. Vogin, MD


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