FDA Approvals, Highlights, and Summaries: Women's Health

February 27, 2020

ExEm Foam (air polymer-type A)

Air polymer-type A is a water-soluble ultrasound contrast gel indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.

Approval of air polymer type A was based on 2 studies that compared 2- and 3-dimensional imaging to detect fallopian tube patency in women with infertility, which was confirmed by laparoscopy with chromotubation as the reference standard. For 2-dimensional sonohysterosalpingography imaging, the proportion of fallopian tubes correctly identified as occluded was 80%, and the proportion of tubes that were correctly identified as patent was 92%. For 3-dimensional imaging, the proportion of tubes correctly identified as occluded was 98%, and the proportion of tubes that were correctly identified as patent was 91%.

ExEm Foam prescribing information

Evenity (romosozumab)

Romosozumab is a monoclonal antibody that binds with and inhibits sclerostin, a regulatory factor in bone metabolism. Sclerostin inhibition increases bone formation and, to a lesser extent, decreases bone resorption. Romosozumab is indicated for osteoporosis treatment in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture. It is also indicated for patients who have failed or are intolerant of other available osteoporosis therapy.

A boxed warning is included in the prescribing information to warn of an increased risk of major adverse cardiovascular events, including myocardial infarction, stroke, and death. Patients who have had a myocardial infarction or stroke within the past year should not receive romosozumab.

FDA approval was based on the FRAME study, which included over 7000 women who had a T score of -2.5 to -3.5 at the total hip or femoral neck. Patients were randomly assigned to receive romosozumab subcutaneous injections (210 mg) or placebo monthly for 12 months. Thereafter, patients in each group received denosumab 60 mg subcutaneously every 6 months for 12 months. Results showed that romosozumab was associated with a lower risk of vertebral fracture compared with placebo at 12 months (representing a 73% lower risk with romosozumab; P<.001). At 24 months, the rates of vertebral fractures were significantly lower in the romosozumab group compared with the placebo group after each group made the transition to denosumab (0.6% [21 of 3325 patients] in the romosozumab group vs 2.5% [84 of 3327] in the placebo group, a 75% lower risk with romosozumab; P<.001).

N Engl J Med. 2016 Oct 20;375(16):1532-1543

Vyleesi (bremelanotide)

Bremelanotide is a melanocortin receptor (MCR) agonist that nonselectively activates several receptor subtypes with the following order of potency: MC1R, MC4R, MC3R, MC5R, MC2R. MCR agonists with high affinity for the type-4 receptor have potential to modulate brain pathways involved in sexual response. It is indicated for acquired, generalized hypoactive sexual desire disorder in premenopausal women.

It is administered as a subcutaneous injection about 45 minutes before an anticipated sexual activity. Approval was based on the RECONNECT clinical trials (n=1247). Results from these trials showed approximately 25% of patients treated with bremelanotide had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2-6, with higher scores indicating greater sexual desire) compared with about 17% of those who took placebo. Additionally, about 35% of the bremelanotide group had a decrease of 1 or more in their distress score (scored on a range of 0-4, with higher scores indicating greater distress from low sexual desire) compared with about 31% of those who took placebo.


Additional 2019 approvals for Women’s Health

Slynd (drospirenone) is a new progestin-only oral contraceptive.

Liletta (levonorgestrel intrauterine) was approved for an expanded duration of use and must be removed by the end of the sixth year following insertion.


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