By Dr. Andrea Lukes, MD, MHSc, FACOG, Chief Medical Officer, Health Decisions

2018 was a positive year for women’s health. We saw the release of groundbreaking treatments targeting female populations. Further, there were increased research efforts to support new drugs and diagnostics focused on health issues that predominantly impact women. These advances promise to improve the quality of life for patients globally and signal an increased focus and investment in treatments for conditions that have long been underserved.

Here are a few of the highlights.

Contraceptive vaginal ring. One of the biggest women’s health stories of 2018 was the U.S. Food and Drug Administration’s (FDA) approval of Annovera, a reusable donut-shaped vaginal contraceptive ring developed by TherapeuticsMD. This contraceptive ring, which can be used for an entire year before being replaced, is the first long-acting prescription birth control that is patient-controlled, procedure-free and fully reversible. Users wear the ring for three weeks, then remove it for a week during which time they may get a period. In December, the FDA classified the segesterone acetate component of the ring as a “new chemical entity,” underscoring the significance of this new approach. There are a number of ongoing studies looking at additional methods for contraception that will be exciting to watch 2019. In particular, new options for male users and those that offer greater user control are advancing.

Treatment for hot flashes. TherapeuticsMD also saw the approval of Bijuva, a combination hormone therapy for moderate to severe vasomotor symptoms (hot flashes) due to menopause in women with a uterus, a condition that impacts more than 40 million women in the U.S each year. It is the first FDA approved bioidentical combination hormone therapy, which means the chemicals have been deemed biologically identical to a woman’s natural hormones. This alternative approach addresses a long unanswered need of both patients and healthcare providers, particularly in situations where there are safety concerns regarding use of conventional estrogen-based treatment options (i.e., in patients who have had breast cancer).

Endometriosis pain relief. Endometriosis is a painful inflammatory disease that affects roughly 10 percent of all menstruating women, yet until 2018, there were limited options for medical management of endometriosis. That changed in July, when the FDA approved Orilissa, a treatment for women with moderate to severe endometriosis pain. The oral treatment, developed by Abbvie with Neurocrine Biosciences, Inc., is the first approved therapy for endometriosis pain in more than a decade, addressing a significant unmet medical need. Abbvie and Neurocrine are now pursuing approval of Orilissa as a treatment to reduce heavy menstrual bleeding related to uterine fibroids. The companies have completed two phase 3 studies showing the drug is effective as a treatment for women with this condition when combined with low-dose hormone therapy. They hope to have FDA approval by mid-2019.

Migraine relief. In 2018, the FDA approved three new migraine prevention treatments, all from a new class of drugs which target either the calcitonin gene-related peptide (CGRP) or CGRP receptor. Amgen’s Aimovig, a once monthly self-administered injection, which targets the CGRP receptor, was approved in May 2018. In September, two medications targeting the CGRP peptide were approved: Teva Pharmaceutical’s Ajovy, an injection with monthly or quarterly dosing options, and Lilly’s Emgality, a once-monthly, self-administered, subcutaneous injection, . Migraines affect 40 million people in the United States, and they are three times more likely to affect women than men, making these new drugs a significant victory for women’s health.

New treatment for HER2-negative breast cancer. In October, the FDA approved Pfizer’s Talzenna, an oral treatment for locally advanced or metastatic HER2-negative breast cancer in women with an inherited BRCA1 or BRCA2 mutation. Talzenna is a poly ADP-ribose polymerase (PARP) inhibitor, which fixes damaged DNA. There are no other treatments specifically approved for this form of breast cancer. An open label study found the treatment has the potential to extend time without disease progression compared to chemotherapy. The FDA also approved a companion diagnostic from Myriad Genetics to identify BRCA mutation status in patients eligible for treatment with Talzenna.

The future of pharma is female

Andrea S. Lukes, MD, MHSc, FACOG,
Chief Medical Officer

Advances in women’s healthcare in 2018 weren’t an anomaly. Over the past several years, we’ve seen a growing interest among global biopharmaceutical companies in pursuing treatments for women’s health needs because they recognize the untapped potential in developing treatments for conditions that affect half of the world’s population. A BCC Research report found that increased global focus on women’s health disorders and an overall aging female population are helping to drive growth of the women’s health pharmaceuticals market, and predict the industry will see a compound annual growth rate of 4.2% through 2023 to $37.4 billion.

Along with the innovative medicines approved last year, there are currently dozens of late phase trials targeting fibroids, endometriosis, reproductive health, migraine and other conditions that affect largely female populations. These trials include the study of a potential biomarker to diagnose endometriosis, which would be a welcome non-invasive alternative for patients.

“While some developments targeting female specific conditions have been groundbreaking, women’s health is about so much more than reproduction, menopause and gynecologic conditions.”

In the coming years we expect this trend to continue. We also hope to see increased involvement of women in clinical trials overall. While some developments targeting female specific conditions have been groundbreaking, women’s health is about so much more than reproduction, menopause and gynecologic conditions. From autoimmune diseases to pain disorders, the healthcare industry should invest more time and research into studying the causes and symptoms of common and chronic health conditions in female patients.

Health Decisions is committed to improving women’s health outcomes through the support of clinical research. Read more about Health Decisions’ expertise in women’s health here.