FDA taking steps to expand access to monkeypox testing
The FDA announced it is taking steps to help further expand monkeypox testing capacity and accessibility nationwide as part of its commitment to addressing the monkeypox outbreak. The agency issued guidance for labs, commercial manufacturers, and FDA staff that outlines its current thinking regarding enforcement policies, recommendations for emergency use authorization (EUA) requests for diagnostic tests, and plans to prioritize reviews of EUA requests.
Since monkeypox was detected in the US in May 2022, the FDA has worked with the CDC to increase production and distribution of the FDA-cleared CDC nonvariola orthopoxvirus test. The organizations have also cleared the use of additional reagents and automation to increase the testing capacity of labs using the test, engaged with commercial manufacturers on developing and validating diagnostic tests and rapid molecular or antigen tests for point-of-care or at-home use, and monitored tests that are in use.
USPSTF draft recommends anxiety screening for all adults under age 65
The US Preventive Services Task Force (USPSTF) issued a draft guidance in September 2022 that for the first time recommends screening adults younger than age 65 for anxiety. The recommendation applies to adults ages 19 to 64 years who do not have a diagnosed mental health disorder or are not showing recognized signs or symptoms of anxiety. "Screening can help identify anxiety and depression in many adults; more research is needed on whether screening can help prevent suicide in adults," a statement notes.
The task force found insufficient evidence on the benefits and potential harms of screening for anxiety in those age 65 and older. The task force continues to recommend screening all adults for depression.
Myfembree now approved for endometriosis pain
The FDA approved Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for treatment of moderate-to-severe endometriosis pain in premenopausal women for up to 24 months. The once-daily pill was originally approved to treat heavy menstrual bleeding linked to uterine fibroids in premenopausal women. Clinical trials showed Myfembree reduced menstrual pain and nonmenstrual pelvic pain in premenopausal women with endometriosis with a loss of mean bone mineral density (BMD) of less than 1% from baseline through 1 year of treatment. In the Myfembree treatment group, 75% of women in two studies achieved a clinically meaningful reduction in dysmenorrhea compared with 27% and 30% of women in the placebo groups at week 24, respectively (both P < .0001).
For nonmenstrual pelvic pain, Myfembree demonstrated a clinically meaningful reduction in pain in 59% and 66% of women, compared with 40% and 43% of women in the placebo groups (P < .0001). Adverse reactions occurring in at least 3% of women treated with Myfembree and greater than placebo included headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness. Annual monitoring of BMD is recommended while treating women with endometriosis. Myfembree is comarketed by Myovant and Pfizer.
Mirena now indicated for 8 years of pregnancy prevention
Mirena (levonorgestrel-releasing intrauterine system 52 mg intrauterine device [IUD]) is now approved for an extended duration of use of an additional year, making it available to prevent pregnancy for up to 8 years. Mirena was previously approved for 7 years of contraception. It is the only FDA-approved IUD to also be indicated to treat heavy periods for up to 5 years in women who choose intrauterine contraception and can be used in women whether or not they have previously given birth.
The approval was based on the results of a phase III extension trial evaluating the efficacy and safety of Mirena that showed the device was well tolerated with no new or unexpected safety findings; Mirena demonstrated contraceptive efficacy greater than 99% during years 6 to 8 of use.