FDA to Review Relugolix Combination Therapy for Uterine Fibroids
The NDA submission is supported by results from the phase 3 LIBERTY program.
Menorrhagia
Sustained Clinical Benefits Observed With Linzagolix in Uterine Fibroid Trials
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.
Linzagolix Reduces Heavy Menstrual Bleeding in Uterine Fibroids Study
Linzagolix is a novel, oral gonadotropin-releasing hormone (GnRH) receptor antagonist, the trial assessed the treatment in 535 women.
Elagolix NDA Submitted for Heavy Menstrual Bleeding With Uterine Fibroids
A New Drug Application for elagolix for the management of heavy menstrual bleeding associated with uterine fibroids has been submitted to the Food and Drug Administration by AbbVie. The NDA is supported by data from two phase 3 studies, ELARIS UF-1 (N=412) and ELARIS UF-2 (N=378) which evaluated the efficacy, safety, and tolerability of elagolix,…
Elagolix + Add-Back Tx Reduces Heavy Menstrual Bleeding in Phase 3 Extension Study
AbbVie plans to submit data from the phase 3 uterine fibroids program to the FDA sometime in 2019.
FDA Warning Ups Hysterectomy Complications for Uterine Fibroids
Among the women who underwent hysterectomy for uterine fibroids, there was a significant increase in major complications (from 1.9 to 2.4%; adjusted odds ratio, 1.23) and minor complications (from 2.7 to 3.3%; adjusted odds ratio, 1.21).
Positive Results for Elagolix in Second Phase 3 Uterine Fibroid Trial
Results – measured by the alkaline hematin method – found that at 6 months those in the combination group had 76.2% (P<0.001) clinical response compared to the elagloix along group, in which only 10.1% had a clinical response.
First-in-Class Oral Tx for Uterine Fibroids One Step Closer to Approval
Ulipristal acetate is a selective progesterone receptor modulator which acts directly on the progesterone receptors in the endometrium, uterine fibroids, and the pituitary gland.
Labeling Updated for IUDs Regarding Perforation Risk
Data from a large, 1-year postmarketing safety study conducted in Europe found that lactation at the time of insertion of an IUD/IUS was associated with an increased risk of perforation.
Amerigen Approved for Generic Lysteda
Amerigen announced that the Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for Tranexamic Acid Instant Release Tablets, the generic version of Ferring’s Lysteda.
