Selected Medicines in Development for Women

October 2005

Alzheimer’s disease affects an estimated 4.5 million Americans and its prevalence among women is twice as high as compared to men. Half of all women over 85 in the U.S. will eventually develop this disease A potential new medicine for Alzheimer’s disease has two mechanisms of action. It blocks the production of beta amyloid protein, which forms plaques in the brain of Alzheimer’s patients, and it inhibits the degradation of the neurotransmitter acetylcholine. A report by researchers at the National Institutes of Health indicates that the medicine may also be able to improve the symptoms of Alzheimer’s patients and may slow the progression of the disease.

Breast cancer will kill an estimated 40,410 American women this year and an estimated 211,240 women will be diagnosed with the disease. One medicine now in clinical trials for metastatic breast cancer is designed to bind to and inhibit vascular endothelial growth factor (VEGF), a protein that plays a critical role in tumor angiogenesis (the formation of new blood vessels that feed the tumor) and maintenance of established tumor blood vessels.

Diabetes affects about 18.2 million Americans. About half of all diabetes cases occur in people older than age 55, and more than 8.6 million Americans age 60 and older have diabetes. An estimated 9.3 million or 8.7% of all women, age 20 years or older, have diabetes. Uncontrolled diabetes can lead to kidney failure, blindness, amputations and premature death. A new, first-in-class medicine in development has been shown in clinical trials to significantly improve long-term glycemic control. The medicine increases levels of a specific hormone (GLP-1) that stimulates insulin production and reduces the secretion of glucagons, by blocking the action of an enzyme (DPP-4) that inactivates the GLP-1 hormone. By increasing levels of GLP-1 the new medicine could improve the imbalance between insulin and glucose that causes type 2 diabetes.

Fibromyalgia syndrome, a chronic pain syndrome, affects an estimated 4 million to 6 million Americans, of which 80 to 90 percent are women. Symptoms can be debilitating and are characterized by chronic and widespread pain throughout the body, often accompanied by severe fatigue and poor sleep. There are no drugs specifically approved in the United States for the treatment of fibromyalgia syndrome. One medicine in development is the first in a new class of drugs known as norepinephrine serotonin reuptake inhibitors. The medicine decreases the uptake of two key neurotransmitters -- norepinephrine and serotonin, which play an essential role in regulating pain and mood.

Osteoporosis is a major public health threat for an estimated 44 million Americans, 80 percent of whom are women. One in two women over the age of 50 will suffer an osteoporosis-related fracture in her lifetime. Bone is constantly being formed and broken down. In a healthy young person, the rate of bone formation and breakdown is balanced. But in older women, breakdown often occurs at a faster rate than formation, resulting in osteoporosis. Currently approved medicines slow the breakdown, or resorption, of bone. A recombinant, injectable version of human parathyroid hormone, a natural occurring protein, may be able to speed up bone formation. Human parathyroid hormone speeds both the formation and resorption of bone, with a net increase of bone formation, raising hope that it may be able to reverse – not just slow – the course of the disease.

Rheumatoid arthritis affects 1.5 million American women. In fact, more than 70 percent of the people with this disease are women. One to three percent of women may develop rheumatoid arthritis in their lifetime. The disease most often begins between the fourth and sixth decades of life; however, RA can develop at any age. In this autoimmune disorder, the joints become painful, swollen, stiff and, in severe cases, deformed. A potential “first in class” medicine modulates the autoimmune T-cell function, which helps to stem the cascade of inflammation that leads to joint damage. In clinical trials the medicine has shown to relieve the signs and symptoms of rheumatoid arthritis.

Systemic lupus erythematosus (SLE or lupus) affects an estimated 1.5 million Americans. Lupus occurs 10 to 15 times more frequently among adult females than adult males and 90 percent of all patients with lupus are women. In lupus, the body develops antibodies that react against normal tissue, leading to inflammation, pain, tissue injury and major organ damage. No new medicine specifically for lupus has been approved in 40 years. Currently, most lupus patients are treated with steroids. But a medicine now in clinical trials shows promise in reducing renal flares, the kidney-destroying inflammation that is the leading cause of illness and death in lupus patients. The flares occur when patients develop antibodies without suppressing the healthy functions of the immune system.