ObsEva SA [NASDAQ: OBSV] disclosed that the New Drug Application (NDA) for Linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been acknowledged for evaluation by the US FDA. This announcement indicates an important achievement not only in the Linzagolix clinical development process, but for Obseva as a company, and more importantly, the millions of women suffering from uterine fibroids throughout the US.
It has been disclosed that the FDA set a target action date of September 13, 2022, for this NDA under the Prescription Drug User Fee Act (PDUFA). The submission is based on data from the two-Phase III PRIMROSE studies. The Phase III PRIMROSE studies of Linzagolix examined the efficacy and safety of two dosing regimens, 100mg once daily and 200mg once daily, alone or in combination with hormonal ABT for the cure of heavy menstrual bleeding associated with uterine fibroids.
Furthermore, the NDA submission includes positive 24-week treatment results from both studies, as well as helpful outcomes from Week 52 and the 76-week post-treatment follow-up. Moreover, the Linzagolix MAA was certified by EMA with an acceptance recommendation from the CHMP probably in Q4 2021.
Additionally, Obseva has declared earlier that the company has entered into a collaboration agreement with Syneos Health to provide support for the promotion of Linzagolix in the US and EU. The company believed that Linzagolix has a diverse profile and if it is accepted, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids.