Zometa

The most urgent task faced by the U.S. Food and Drug Administration (FDA) in the wake of the terrorist attacks on September 11, 2001, was to assure the availability of medical products for the treatment of injuries that could be caused by terrorists using biologic, chemical, or nuclear agents. Responding to this challenge, the agency's medical product centers--the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH)--rapidly launched numerous initiatives.

CDER clarified that the antibiotics doxycycline and penicillin G procaine are effective and approved for use in treating all forms of anthrax. CBER worked closely with industry and other government agencies to assure an adequate supply of products for immunization against anthrax, botulinum, small pox, and similar substances. CDRH contributed to the development of methodology for the detection of biologic agents that could be used for bioterrorism.

Product Approvals

The counter-terrorism programs were carried out in addition to the FDA's routine review and approval of medical products, which in 2001 included a breakthrough drug for cancer, the first biologic treatment for the most serious type of sepsis, and an advanced device for monitoring glucose levels in blood. CDER approved 66 new drugs, 24 of which were new molecular entities with ingredients not previously marketed in the United States (Table 1). CBER approved 16 complex biologic license applications, most of which were designed to detect or treat infections (see Table 2 on page 2383). CDRH approved 54 premarket approvals, of which 24 were for devices with novel technologies or new uses.

Cancer Patients

One of the FDA's most important approvals last year was for imatinib mesylate or STI-571 (Gleevec), a new oral treatment for patients with chronic myeloid leukemia. In addition to two cancer drugs for women, the FDA approved alemtuzumab Campath, a new biologic product for the treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and failed fludarabine therapy.

Women and Children

The first of two cancer products for women, a combination of capecitabine (Xeloda) and docetaxel (Taxotere), was approved for the treatment of metastatic breast cancer that has not responded to an anthracycline-containing cancer therapy.

The other approval was a new indication for letrozole (Femara) as a first-line treatment for advanced or metastatic breast cancer in postmenopausal women with hormone receptor-positive or unknown disease.

In addition, two contraceptive devices that deliver continuous doses of progestin and estrogen hormones were approved. One of the devices, Ortho Evra, is the first skin patch approved for birth control, and the other, NuvaRing, delivers the hormones through a flexible, transparent polymer ring that is inserted into the vagina.

The FDA also approved the first automatic external defibrillator (AED) system for use on infants and young children who experience cardiac arrest.

Heart Patients

In addition to the AED system for use on infants and young children, the FDA approved the following four highly advanced medical devices for heart patients: Biotronik Home Monitoring System, the first implanted pacemaker that includes a tiny transmitter capable of automatic, remote data transmission; the Wearable Cardioverter Defibrillator System, a vest-like device that is worn under clothing to monitor and treat abnormal heart rhythms in people at risk of dying from sudden cardiac arrest; InSync Biventricular Cardiac Pacing System, a new type of pacemaker that sends specially timed electric impulses to the heart's lower chambers to treat the symptoms of moderate to severe congestive heart failure; and PercuSurge, a device consisting of balloon and aspiration catheters, which is used to collect and remove blood clots and other debris created by angioplasty and stenting of a blocked bypass vein graft.

Nesiritide (Natrecor), a new drug approved for cardiac patients, is an injection treatment for acute congestive heart failure. The medication, which was developed with the use of recombinant DNA technology, is a synthetic version of human hormone that dilates veins and arteries.

Infectious Diseases

Xigris is the first biologic treatment approved for the most serious forms of life-threatening sepsis, which claims 225,000 lives in the United States each year. The new treatment is a genetically engineered version of a naturally occurring human protein, Activated Protein C, which interferes with some of the body's harmful responses to severe infection.

Peginteferon alfa-2b (PEG-Intron) injection was approved for the treatment of patients with chronic hepatitis C, an infectious disease responsible for as many as 10,000 deaths per year in the United States. PEG-Intron is a longer acting form of interferon than Intron A (a previously approved form of interferon) and requires only one injection per week for one year compared with three per week for Intron A. The FDA also approved a supplemental application for the use of PEG-Intron with ribavirin (Rebetol) capsules, which was shown to be somewhat more effective than Intron A with Rebetol.

In addition, the FDA approved Twinrix, a new combination vaccine that protects adults against diseases caused by the hepatitis A virus (HAV) and the hepatitis B virus (HBV). Twinrix is recommended for travelers who are at high risk for HBV and are visiting countries where there is a substantial incidence of HAV and HBV disease.

Caspofungin acetate (Cancidas) intravenous infusion is a new antifungal medication for patients not responsive to or unable to tolerate standard therapies for the invasive form of aspergillosis. This is the first approval in a new class of drugs called echinocandins, which are believed to work by disrupting the creation of fungal cell walls.

Tenofovir disoproxil fumarate (Viread) is a new antiviral drug for the treatment of human immunodeficiency virus-1 (HIV-1) infection in combination with other antiretroviral medicines. Viread is the first nucleotide analog approved for HIV-1 treatment.

Other Important Approvals

Bimatoprost ophthalmic solution (Lumigan) and travoprost ophthalmic solution (Travatan) are new medications to treat the elevated intraocular pressure often associated with glaucoma. The solutions are indicated for use in patients who are intolerant of other intraocular pressure-lowering medications.

Darbepoetin (Aranesp), a new biologic agent, was approved for treatment of anemia associated with chronic renal failure, whether or not patients are on dialysis.

The agency also approved the first HIV drug resistance test for use as an aid in monitoring and treating HIV-infected patients. The test detects mutations in HIV that confer resistance to drugs used to treat the infection.

Novel devices approved in 2001 included GlucoWatch Biographer, a wristwatch-like device that provides adult diabetics with more information for managing their disease, and Lap-Band Adjustable Gastric Banding System, an inflatable device that is surgically placed around the upper stomach to limit food consumption and create an earlier feeling of fullness. This device is intended for use in people at least 100 lb overweight who have failed to reduce their weight by dieting and other methods, and who are at greater risk for serious diseases such as hypertension, gall bladder disease, and diabetes. The FDA also cleared a new device that produces images that help detect bleeding of the small bowel inner lining.

The complete new drug approval tables are available at this Web site: www.fda.gov.

Thomas J. McGinnis, R.Ph., is director of pharmacy affairs in the Office of Policy of the U.S. Food and Drug Administration.

COPYRIGHT 2002 American Academy of Family Physicians
COPYRIGHT 2002 Gale Group