FDA approves the first generic Climara Pro, a weekly hormone patch for menopause
Zydus makes the generic version of Bayer's combined estrogen and progestogen patch. It treats moderate to severe hot flashes and helps prevent bone loss after menopause in women who still have a uterus.
The Food and Drug Administration approved the first generic version of Climara Pro on Oct 19. The patch goes on the skin once a week and releases two hormones: estradiol at 0.045 mg a day and levonorgestrel at 0.015 mg a day. Zydus Pharmaceuticals (USA) Inc. makes the generic. Climara Pro is a Bayer brand.
FDA rates the generic as therapeutically equivalent to Climara Pro. That is the agency’s term for a generic expected to work the same way as the brand.
Who it is for
The label covers women who still have a uterus, for two uses. The first is moderate to severe hot flashes and night sweats from menopause, which FDA calls vasomotor symptoms. The second is prevention of osteoporosis after menopause.
The patch pairs estrogen with a progestogen in one patch. FDA notes that the patches commonly used for menopause carry estrogen only. Estrogen alone can thicken the lining of the uterus, a condition called endometrial hyperplasia, and the progestogen is there to lower that risk, FDA says.
What the label rules out
FDA lists the patients who should not get it. The list includes women with undiagnosed abnormal genital bleeding, breast cancer now or in the past, or cancers that depend on estrogen. It also covers blood clots in the legs or lungs now or in the past, arterial clotting disease, liver disease and certain inherited clotting disorders. Anyone allergic to either hormone is excluded too.
Side effects reported in 5% or more of patients include skin reactions where the patch sits, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome.
Why now
The approval landed four days after the American College of Obstetricians and Gynecologists published its broadest menopause guidance to date, on Oct 15. ACOG says 50% to 92% of women in menopause report hot flashes or night sweats. For patients who choose hormone therapy, ACOG recommends starting before age 60 or within 10 years of menopause, absent reasons to avoid it.
It also follows other federal moves on menopause care this year. HHS says FDA began removing broad boxed warnings from hormone therapy products and approved a generic Premarin, the first in more than 30 years.
“Menopause is a universal experience for women, and it can greatly affect a person’s quality of life,” Acting FDA Commissioner Kyle Diamantas said. Michael Davis, who directs FDA’s drug center, said a weekly patch “offers a convenient alternative to daily oral medications.”
Price and launch
FDA gave no price or launch date. The agency tells patients to contact the manufacturer for availability. Nine in 10 prescriptions filled in the US are for generics, FDA says. The agency points to generic competition as the way treatment becomes more affordable.
Why it matters
Climara Pro now has a generic competitor, and in the US, generic entry is how drug prices come down.
