dm+d

Unassigned

New Medicines

Yselty Uterine fibroids - reducing symptoms including pain, discomfort from heavy menstrual bleeding and anaemia

Information

Yselty
New molecular entity
ObsEva SA
ObsEva SA

Development and Regulatory status

None
Pre-registration (Filed)
Phase III Clinical Trials
May 21ObsEva are preparing for commercial launch of linzagolix in EU; submission of NDA to FDA is now planned for Q3 21 [5].
Jan 21the EMA has validated application for linzagolix (Yselty), treatment for women suffering from heavy menstrual bleeding associated with uterine fibroids [3].
Dec 20US filing is planned for H1 21 [4].
Jul 20PIII trials completed, ObsEva now preparing its regulatory submissions to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), anticipating submitting to EMA in 4Q 2020 [1].

Category

Once daily oral GnRH receptor antagonist
Uterine fibroids are benign tumours of the uterine muscle, affecting women of childbearing age and varying in size from undetectable to a large mass. Symptoms are wide-ranging and include heavy menstrual bleeding, anemia, pelvic pressure and bloating, urinary frequency and pain [1]. Fibroids are the most common indication for hysterectomy [2].
Uterine fibroids - reducing symptoms including pain, discomfort from heavy menstrual bleeding and anaemia
Oral

Trial or other data

May 21Final 76-week results from PRIMROSE 1 show sustained post-treatment effects and evidence of BMD recovery following 52 weeks of treatment [6].
Jul 20PRIMROSE 2 PIII trial demonstrated that continued treatment with linzagolix for 52 weeks provides sustained efficacy and was well tolerated. Responder rates of 91.6% and 53.2% were observed in women receiving 200 mg with ABT and 100 mg without ABT, respectively, both of which are similar to the responder rates observed at week 24 of the study [1].
Jul 20Results of PIII trials announced. PRIMROSE 1 met its primary endpoint at week 24 finding that women with fibroids receiving linzagolix experienced a statistically significant and clinically meaningful reduction in menstrual blood loss (≤80 mL and a ≥50% reduction from baseline) compared to placebo. Women receiving 200 mg with hormonal add back therapy (ABT) achieved a 75.5% (P<0.001) responder rate and those receiving 100 mg without ABT achieved a 56.4% (P=0.003) responder rate [1].

Yselty Endometriosis-associated pain

Information

Yselty
New molecular entity
ObsEva SA
ObsEva SA

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Oral GnRH receptor antagonist
Endometriosis is estimated to affect 10-15% of women of reproductive age. However, it is difficult to determine the prevalence because of the diversity of symptoms and their severity and because endometriosis may be asymptomatic [3].
Endometriosis-associated pain
Oral