FDA to Review Relugolix Combination Therapy for Uterine Fibroids
The NDA submission is supported by results from the phase 3 LIBERTY program.
The NDA submission is supported by results from the phase 3 LIBERTY program.
Positive topline data were announced from two phase 3 studies evaluating the efficacy and safety of linzagolix (Yselty®; ObsEva) for the treatment of heavy menstrual bleeding due to uterine fibroids.
Positive topline results were announced from the phase 3 SPIRIT 1 study investigating relugolix (Myovant Sciences), in combination with estradiol and norethindrone acetate, in women with pain associated with endometriosis.
The FDA has approved Oriahnn™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules; AbbVie) for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
The FDA has approved Advil Dual Action with Acetaminophen (GlaxoSmithKline), the first over-the-counter (OTC) fixed-dose combination therapy containing ibuprofen and acetaminophen for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis. Each caplet contains 125mg of Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID)…
Endometriosis is most common cause of secondary dysmenorrhea, looks different in teens than adults
Researchers at the National Institute of Environmental Health Sciences (NIEHS), Vanderbilt University Medical Center, and the Henry Ford Health System analyzed patient data from African-American women aged 23 to 35 years (N=1553) who were participating in the NIEHS Study of Environment, Lifestyle, and Fibroids (SELF).
The approval was based on data from 2 multinational double-blind, placebo-controlled Phase 3 trials involving 1686 premenopausal women with moderate to severe pain associated with endometriosis.
No new safety concerns were identified with elagolix use for the 12-month treatment period
Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, was evaluated in two Phase 3 clinical studies in about 1,700 women with moderate-to-severe endometriosis-associated pain.