| Drug Name |
FEMLYV™ (ethinyl estradiol and norethindrone acetate) |
| Active Ingredient |
ethinyl estradiol and norethindrone acetate |
| Date of Approval |
July 22, 2024 |
| Manufacturer |
Millicent Puerto Rico LLC |
| Approval Pathways and Indications |
Approval Pathway: NDA
Indication: FEMLYV™ is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy |
| Therapeutic Class |
Hormonal contraceptives |
| Formulation |
Orally disintegrating tablets(ODTs) |
| MoA |
Combined hormonal contraceptives (CHC) lower the risk of becoming pregnant primarily by suppressing ovulation. |
| Dosing and Administration |
Dosing: Each package includes 24 ODTs each containing 1 mg norethindrone acetate and 0.02 mg ethinyl estradiol and 4 inert ODTs
Administration: The recommended dosage and administration for FEMLYV™ involves taking one green ODT daily for 24 consecutive days, followed by one white ODT daily for 4 days, starting either on the first day of menstruation or the first Sunday after menstruation begins. The tablets should be taken at the same time each day, placing one FEMLYV™ ODT on the tongue, letting it disintegrate, and then followed with 8 oz. (240 mL) of water, with non-hormonal contraception recommended for the first 7 days if FEMLYV™ is started on a day other than the first day of menstruation.
When switching to FEMLYV™ from another contraceptive method:
COC: Start FEMLYV™ on the day a new pack of the previous COC would begin.
Transdermal system: Start FEMLYV™ on the day the next application would be scheduled.
Vaginal insert: Start FEMLYV™ on the day the next insertion would be scheduled.
Injection: Start FEMLYV™ on the day the next injection is due.
IUS or implant: Start FEMLYV™ on the day of removal.
Progestin-only pill: Start FEMLYV™ after the last tablet.
Missed doses:
One green active ODT: Take as soon as possible and continue the next dose at the regular time. No additional contraception needed.
Two green active ODTs (Week 1 or Week 2): Take both missed doses as soon as possible, followed by two doses the next day. Use additional non-hormonal contraception for 7 days.
Two green active ODTs (Week 3 or Week 4):
Day 1 starters: Discard the rest of the pack and start a new one immediately.
Sunday starters: Continue taking one ODT daily until Sunday, then discard the rest and start a new pack on Sunday. Use additional non-hormonal contraception for 7 days.
Three or more green active ODTs:
Follow the same instructions as for two missed ODTs in Week 3 or Week 4. Bleeding may occur. Use additional non-hormonal contraception for 7 days.
White inert ODTs: Discard missed doses and continue as scheduled. No additional contraception needed.
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| Administered by self or by HCP |
Adminsitered by Self |
| Place in Therapy |
FEMLYV™ is the first orally disintegrating tablet to receive FDA approval for pregnancy prevention, though norethindrone acetate and ethinyl estradiol have been approved in a swallowable tablet form for preventing pregnancy since 1968.
“There are many variables that might cause someone to have difficulty swallowing,” said Janet Maynard, MD, MHS, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”
Contraindications for FEMLYV™ include a high risk of venous thrombotic diseases, breast cancer, liver tumors, undiagnosed abnormal uterine bleeding, and co-administration with certain Hepatitis C drug combinations. FEMLYV™ should not be used by women aged over 35 years who smoke. Patients should discontinue FEMLYV™ use following the incidence of a thrombotic event, as well as if blood pressure significantly increases. Other events that may lead to discontinuation include diagnosis of a hormonally sensitive malignancy, chronic disturbance of liver function, and symptomatic gallbladder.
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| Expected Market Launch Date |
Data Unavailable |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
Data Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
The effectiveness of FEMLYV™ for preventing pregnancy in females of reproductive potential is based on well-controlled studies of norethindrone acetate/ethinyl estradiol tablets. In a clinical study involving 743 women aged 18 to 45, efficacy was assessed over six 28-day cycles, totaling 3,823 treatment cycles. The study's racial demographics were 70% Caucasian, 16% African American, 10% Hispanic, 2% Asian, and 2% Other, excluding women with a BMI over 35 kg/m². The weight range of participants was 90 to 260 pounds, with a mean of 147 pounds. Approximately 40% had not used hormonal contraception before the study, and 583 women completed all six cycles. There were five on-treatment pregnancies in 3,565 treatment cycles without backup contraception, resulting in a Pearl Index of 1.82 (95% CI 0.59 - 4.25). |
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https://www.fda.gov/news-events/press-announcements/
fda-roundup-july-23-2024
https://www.contemporaryobgyn.net/view/
fda-approves-femlyv-as-the-first-orally-disintegrating-tablet-for-pregnancy-prevention
https://www.accessdata.fda.gov/
drugsatfda_docs/label/2024/218718s000lbl.pdf
https://www.drugs.com/newdrugs/fda-approves-femlyv-norethindrone-acetate-ethinyl-estradiol-orally-disintegrating-birth-control-pill-6330.html
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