Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) announced an update for an sNDA for MYFEMBREE, which is designed to manage severe to moderate pain linked to endometriosis.
According to the ongoing review of this new application, the FDA provided notice that it had identified some deficiencies that preclude talks of post-marketing and/or labeling requirements. This review was conducted on April 6, 2022.
Details about the drug
Pfizer and Myovant will continue working closely with the FDA to figure out the next steps with this new drug application.
MYFEMBREE is the first single-application oral treatment to treat heavy menstrual bleeding linked to uterine fibroids in females undergoing premenopausal that the FDA has approved. The entire treatment is meant to run for two years. The new drug application features relugolix, which helps reduce the amount of estrogen produced by the ovaries.
It also contains estradiol, an estrogen that can help reduce bone loss, and norethindrone, a progestin that is essential for women who take estrogen and have a womb.
The drug is contradicted in females highly prone to thromboembolic, venous thrombotic, arterial disorder, osteoporosis, or other hormone-sensitive malignancies. It’s also contradicted to women over the age of 35 who smoke or those with uncontrollable hypertension episodes.
Warnings and precautions associated with the drug
MYFEMBREE might cause a reduction in bone density in some patients. The patient can suffer even more bone loss depending on how long they use the drug, and sometimes the effects of this may be irreversible even after they have stopped the treatment.
Before using the drug, you’ll need to consider both the risks and benefits in people prone to osteoporosis or with a low trauma fracture history.
Also, patients with symptoms of depression or severe mood changes might want to avoid using this new drug application. The risks can sometimes outweigh the benefits in these cases.
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