FDA accept New Drug Application for Obseva’s linzagolix

pharmafile | November 22, 2021 | News story | Sales and Marketing  

Obseva, a biopharmaceutical company developing and commercialising novel therapies to improve reproductive health, have announced that the NDA for linzagolix has been accepted for review by the FDA. Linzagolix manages the heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

The submission is based upon data from the two Phase III PRIMROSE trials. The trials investigated the efficacy and safety of two dosing regimens: 100mg once daily and 200mg once daily, alone or in combination with hormonal ABT (1mg estradiol and 0.5mg norethisterone acetate).

Linzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones.

“Today marks an important milestone not only in the Linzagolix clinical development process, but for Obseva as a company, and most importantly, the millions of women living with uterine fibroids throughout the US. Linzagolix is a significant innovation in the field of women’s health – an area that is consistently underinvested in – and we are incredibly excited about the potential of bringing this important treatment to the market,” said Brian O’Callaghan, CEO of Obseva. “We are encouraged by our positive Phase III PRIMROSE results. If approved, we believe Linzagolix will address a significant unmet need in offering a more individualised treatment option for a broader range of women.”

Uterine fibroids are common benign tumors of the muscular tissue of the uterus which affect women of childbearing age. Uterine fibroids can vary in size from undetectable to large bulky masses. Few long-term medical treatments are available, and as a result, approximately 300,000 hysterectomies are performed for uterine fibroids every year in the US. Symptoms include heavy menstrual bleeding, anemia, and pain that can be extremely debilitating with a significant impact on quality of life.

Ana Ovey

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