Despite NIH and FDA women’s health policy initiatives previously described in this blog, the list of novel drugs approved by FDA in 2016 includes only one product for a woman-specific health indication. FDA granted accelerated approval in December 2016 for rucaparib (Rubraca™), a Clovis Oncology PARP inhibitor for ovarian cancer. Rubraca is indicated for patients with advanced disease and a deleterious BRCA mutation (germline and/or somatic) who have been treated with two or more chemotherapies. As ovarian cancer has only a 45% 5-year survival rate, new treatment options in this indication are important.
The Gap Between Unmet Needs and the Product Pipeline
In view of the initiatives referenced above and the substantial number of health conditions that are woman-specific, it is surprising that 2016 did not see more approvals of novel drugs in this area. After all, the list of such health conditions is extensive:
- cancers – breast, ovarian, cervical, endometrial, fallopian, peritoneal, vulval, vaginal …
- gynecologic conditions – endometriosis, uterine fibroids, menstrual irregularities, pelvic floor disorders, bacterial vaginosis, vaginitis, vulvodynia, pelvic inflammatory disease …
- fertility-related conditions – polycystic ovary syndrome, primary ovarian insufficiency, fallopian tube occlusion …
- pregnancy-associated conditions – gestational diabetes, preeclampsia, preterm birth, hyperemesis gravidarum, miscarriage, placenta previa, ectopic pregancy, pain following vaginal and cesarean delivery, postpartum depression …
On a positive note, 2016 did see approval of Biogen’s daclizumab (Zynbryta™) for multiple sclerosis, a disease that affects women at a rate 2x-3x the rate for men. But as with drugs for woman-specific indications, a look back at 2016 leaves the impression that academic research and the pharma industry should be producing a greater number of drugs for indications that are more common in women. Indications in this category include not only multiple sclerosis, but also lupus erythematosus (9x female:male), type 1 osteoporosis (8x), fibromyalgia (7x), rheumatoid arthritis (4x-5x for women ≤ 50 years of age, 2x-3x overall), migraine (3x), eating disorders (3x), celiac disease (2x-3x), depressive disorders (2x) and Alzheimer’s disease (1.5x) .
Prioritizing Unmet Needs for an Underserved Majority
As a CRO with a substantial focus on and commitment to women’s health and a variety of related active studies, Health Decisions is aware that pharma pipelines are progressing a number of products for women. Nevertheless, we are convinced that the number of drug candidates for woman-specific indications should be greater than it is. Women make up more than half of the population of the United States – they are not an underserved minority but an underserved majority. They also play a disproportionate role in healthcare, as the leading consumers of healthcare and the primary healthcare decision-makers for their families.
FDA appropriately prioritizes development of novel products that address significant unmet medical needs in specific indications. A broader perspective on significant unmet medical needs leaves the strong impression that women have more than their fair share of unmet needs as we approach the third decade of the 21st Century.
Time for a Bold R&D Initiative in Women’s Health
The Women’s Health Initiative launched in 1993 was a single study enrolling 161,808 women and addressing a few areas in women’s health, such as hormone therapy, dietary modification and calcium and Vitamin D supplementation. While the initiative was commendable, the breadth and depth of remaining unmet medical needs in women’s health demand something greater. Furthermore, other initiatives and policies to date are simply not producing adequate results. Perhaps the time has come for a program on the order of President Obama’s Precision Medicine Initiative or President Nixon’s War on Cancer.
Addressing women’s unmet medical needs demands an initiative – by whatever name – that addresses these needs in the aggregate rather than piecemeal. This must include substantially greater funding for discovery and development of novel products for woman-specific and woman-disproportionate indications.