More than 600 drugs in development for diseases affecting women

WASHINGTON, March 31, 2022 /PRNewswire/ — As we near the end of the Women’s History Month observance, Pharmaceutical Research and Manufacturers of America takes a closer look at the biopharmaceutical advances being made and the challenges facing women’s health.

Innovations in women’s health extend and prolong life. In the case of breast cancer, the second leading cause of cancer death in women, mortality rates fell by 42% between 1989 and 2019. In the case of cervical cancer, which is almost always caused by the human papillomavirus (HPV), the widespread use of the HPV vaccine has resulted in the prevalence of HPV infection in adolescent girls of 86% and 71% in young adult women since the vaccine was used in United States. And today, we now have a treatment for endometriosis, a painful condition caused when tissue similar to the lining of the uterus grows outside of the uterus.

These advances are part of a biopharmaceutical ecosystem that continues to provide innovative new therapeutic solutions for women’s health. In a new report, PhRMA explores the research and development pipeline of drugs in clinical trials or under review by the U.S. Food and Drug Administration (FDA) for diseases that only or disproportionately affect women.

Although considerable progress has been made, women face unique health challenges throughout their lives. Women are more likely to be diagnosed with certain diseases than men – like autoimmune diseases, depression, osteoporosis, Alzheimer’s disease and more. Nearly 40% of women will be diagnosed with a chronic disease, compared to 30% of men. Additionally, due to gender bias in health care, women can also be misdiagnosed, which can ultimately delay proper care and treatment. Minority patients may face additional challenges due to racial disparities in health care.

Additionally, while the COVID-19 pandemic has had a negative impact on the mental health of all Americans, women bear a disproportionate share of it. Gender roles, family responsibilities for caring for children and elderly family members, combined with participation in the labor market, contribute to the unique mental health issues faced by women.

To address these challenges, US research-based biopharmaceutical companies are developing 625 drugs targeting diseases that disproportionately or only affect women. Among the drugs are:

  • 200 medicines for cancers mainly affecting women, including 119 for breast cancer, 66 for ovarian cancer, 4 for uterine cancer and 22 for cervical cancer. It is estimated that, all together, these cancers will kill more than 76,000 women in 2022.
  • 133 for neurological disorders including Alzheimer’s disease, migraine and multiple sclerosis.
  • 87 for autoimmune diseases, which are twice as common in women, including lupus, myasthenia gravis, scleroderma and Sjogren’s syndrome.
  • 45 for mental health disorders, which are also twice as common in women, including anxiety disorders, depression, postpartum depression and eating disorders.
  • 43 for respiratory diseases that disproportionately affect women, including asthma and chronic obstructive pulmonary disease.
  • 37 for arthritis and musculoskeletal disorders, including fibromyalgia, osteoporosis and rheumatoid arthritis.
  • 34 for eye diseases, including dry eye.
  • 33 for obstetrical/gynecological health conditions, including endometriosis, menopausal symptoms, polycystic ovary syndrome, pregnancy complications and uterine fibroids.
  • 23 for infectious diseases affecting women, including candidiasis, chlamydia, genital herpes and urinary tract infections.
  • 14 for other conditions that disproportionately affect women, including chronic fatigue syndrome, interstitial cystitis, irritable bowel syndrome, and urinary incontinence.

Clinical trials are essential to bring new medicines to patients. The biopharmaceutical industry is committed to taking steps to improve the diversity of clinical trial participants, including with respect to sex/gender. Improving the diversity of clinical trial populations can lead to studies that better reflect the patient populations most likely to use the product once it is approved. This may include understanding how pregnant or breastfeeding women can safely participate in the clinical trial process, where appropriate.

Policy makers have recently taken a number of steps to better understand how medicines can affect pregnant and breastfeeding women. For example, the Working Group on Research Specific to Pregnant and Breastfeeding Women (PRGLAC), created within the framework of the 21st Cures of the Century Act December 2016, proposed a list of recommendations and an implementation plan to the US Secretary of Health and Human Services to promote the inclusion and integration of pregnant and breastfeeding women in clinical research. Additionally, the FDA has issued guidance for industry on including pregnant women in clinical trials, providing recommendations on how and when to include pregnant women in drug development trials. medications. Finally, the PDUFA VII Goals Letter, negotiated by industry and the FDA, contains commitments to further improve understanding of drugs used in pregnant and breastfeeding women. This includes new Sentinel demonstration projects to assess pregnancy outcomes in women and the development of a framework addressing the use of pregnancy registries and electronic healthcare data sources, including Sentinel , with the aim of ensuring the most effective means of obtaining the highest quality safety data available.

As we look to the future, US research-based biopharmaceutical companies are making significant progress in developing new treatments and cures for diseases that disproportionately affect women.

To learn more, please read our report Drugs in Development for Women click here.

CONTACT: Andrew Powaleny, [email protected]202-835-3460

SOURCE Pharmaceutical Research and Manufacturers of America (PhRMA)