End-of-year approvals - overview of drugs and products receiving FDA approval at the end of 1997 - Brief Article

A device alternative to hysterectomy for excessive menstrual bleeding, as well as medical products to treat osteoporosis, diabetic ulcers, kidney transplant rejection, and a cancer of the immune system were some of the products FDA approved as 1997 came to a close.

* Evista (raloxifene), one of a new class of drugs called selective estrogen receptor modulators (SERMs), can help prevent bone thinning from osteoporosis primarily in postmenopausal women. Clinical data on Evista indicate that it acts like estrogen, though to a lesser degree, in increasing bone density and lowering blood lipids, and it did not adversely affect breast and uterine tissue. Unlike estrogen, however, it does not increase "good cholesterol" levels.

The most serious side effect associated with Evista is increased risk of blood clots. Women with a history of blood clots in their veins should not use the drug. Also, women who are pregnant or may become pregnant should not use the drug because of its potential danger to fetuses.

Manufacturer: Eli Lilly and Co., of Indianapolis.

In a clinical study, twice as many patients who took Fortovase had undetectable virus levels in the blood at 16 weeks of treatment compared with those who took Invirase.

Fortovase was the first HIV drug approved after an FDA advisory committee recommended a more stringent reporting system for clinical study results.

Manufacturer: Hoffmann-La Roche Inc. of Nutley, N.J.

* Meridia (sibutramine) is an appetite suppressant to be used along with a reduced-calorie diet to help manage obesity, a chronic disease that contributes to 300,000 deaths annually in this country.

The drug works by inhibiting the reuptake of the neurotransmitters norepinephrine and serotonin. During clinical trials, there were no reports of pulmonary hypertension, a rare but serious side effect of the anti-obesity drugs fenfluramine and dexfenfluramine, which were taken off the market in September 1997. Also, echocardiograms showed no more valve disease in patients on Meridia than those on placebo.

Manufacturer: Knoll Pharmaceutical Co., of Mount Olive, N.J.

* Neumega (interleukin eleven) reduces the need for frequent platelet transfusions following high-dose chemotherapy. Platelet transfusions, while very safe, carry small risks of infectious disease transmission and bacterial contamination.

Neumega is injected daily under the skin when chemotherapy ends. In clinical studies, 28 percent of patients treated with Neumega avoided platelet transfusions, compared with 3 percent in the untreated group. Possible side effects include fluid retention, which can be a serious problem for some patients, and abnormal heart rhythms, which in studies returned to normal when the treatment ended.

Neumega is not effective for patients undergoing bone marrow transplants.

Manufacturer: Genetics Institute Inc., of Cambridge, Mass.

* Propecia is the first hair loss treatment in pill form. It is marketed for men only because, in women, it causes birth defects and has not otherwise been shown to be safe and effective.

The drug's active ingredient, finasteride, was first approved in a larger dose as a treatment for prostate enlargement.

Manufacturer: Merck and Co., of West Point, Pa.

* Regranex Gel (becaplermin) is the first biotechnology product for treating and healing deep diabetic foot and leg ulcers. These ulcers, which about 15 percent of the country's 16 million diabetics develop, increase the risk of infection and amputation.

The gel is used topically, along with standard ulcer management measures.

Manufacturer: Ortho-McNeil Pharmaceutical, of Raritan, N.J.

* Rituxan (rituximab) is the first biotechnology product to treat patients who have a cancer of the immune system called low-grade B-cell non-Hodgkin's lymphoma and who have not responded to chemotherapy or other standard treatments. FDA reviewed the license application in five months and approved the product in nine.

By targeting and destroying specific white blood cells involved in the disease, Rituxan shrinks tumors with less severe side effects than most cancer treatments.

Manufacturer: IDEX Pharmaceuticals Corp., of San Diego, and Genentech Inc., of San Francisco.

* ThermaChoice is a uterine balloon catheter heat system alternative to hysterectomy or surgical destruction of the uterine lining when excessive, non-cancerous menstrual bleeding can't be controlled by drugs. The outpatient procedure is usually done without general anesthesia and takes about a half hour. Studies showed it safely controlled bleeding for at least one year in more than 80 percent of participants.

As the balloon heat treatment also destroys the lining, it is not for use in women who still plan to have children. Pregnancy is possible after treatment if some lining cells survive. However, scientists believe such pregnancies would carry considerable risk to the mother and fetus, so treated women must use effective contraception or undergo sterilization.

Manufacturer: Gynecare-Ethicon Inc., of Menlo Park, Calif.

* Tobi (tobramycin for inhalation) is the first inhaled antibiotic for people with cystic fibrosis, an inherited condition that can lead to diminished lung function and chronic lung infections. Tobi suppresses Pseudomonas aeruginosa bacteria, a potentially dangerous microorganism that affects the lungs or respiratory system of most people with cystic fibrosis.

A reformulation of the injectable form of tobramycin, which FDA approved in 1975, Tobi helped improve lung function and reduce bacteria in sputum in clinical trials. Side effects included voice alteration and ringing in the ears.

Manufacturer: PathoGenesis Corp., of Seattle.

* Toronto SPV Valve is a new type of heart valve for adults with defective natural or prosthetic aortic valves. The tissue valve, taken from a pig, is supported by the patient's aorta, unlike previous tissue valves, which require metal or plastic supports called stents. With increased space from elimination of the stent, doctors can implant larger valves for improved blood flow.

In a study of about 600 patients ages 33 to 93 in the United States, Canada, and the United Kingdom, the new valve was safe and provided good blood flow.

Manufacturer: St. Jude Medical Inc., of Minneapolis.

* Transderm Scop (scopolamine patch) is a small, tan-colored patch that is placed behind the ear before surgery to prevent the nausea and vomiting related to some pain relievers and anesthesia.

Each patch should be used only once and for no longer than three days. It should not be used by children.

Manufacturer: Novartis Consumer Health, of Summit, N.J.

* Zenapax (daclizumab) is the first monoclonal antibody to help prevent acute kidney transplant rejection. Used with a standard course of immunosuppressive therapy, it helps prevent rejection with minimal additional side effects.

FDA reviewed and approve the license application for this biologic in six months.

Manufacturer: Roche Laboratories Inc., of Nutley, N.J.

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