Endometriosis is an indication that needs new therapy options. The variety of symptoms across cases, non-specificity of symptoms, and overlap of symptomology with other conditions make it difficult to manage, with cases often being misdiagnosed. According to GlobalData’s Pharma Intelligence Center database, there are 46 pipeline drugs currently being developed for endometriosis worldwide*. The leading data and analytics company notes that ObsEva’s Yselty, a gonadotropin-releasing hormone (GnRH) receptor antagonist, represents one of those 46 therapies and provides promise in the endometriosis drug market.
ObsEva announced in August 2021 that the company expects an EDELWEISS 3 data readout during Q4 2021.
Sarah Bundra, Pharmaceutical Analyst at GlobalData comments: “Phase III data from ObsEva’s EDELWEISS 3 study will be very important in determining the potential success of Yselty in the endometriosis market. The therapy faces competition from two other GnRH antagonists, Myovant/Pfizer’s relguolix and AbbVie’s Orilissa (elagolix sodium), making Yselty a third-to-market entrant in its class. This would put ObsEva at a significant disadvantage; however, uptake of Orilissa has been poor, signalling the need for more effective endometriosis GnRH antagonists.
“Orilissa is available at 150mg and 200mg dose options, with the higher dosage option contributing to considerable bone mineral density (BMD) loss. BMD loss has been a historically problematic side effect of many endometriosis medications, so if EDELWEISS 3 indicates success in that area, then ObsEva would have an edge over its competitors.”
Yselty provides promise in the endometriosis drug market because of its ability to alleviate pain, minimize adverse effects such as BMD loss, and the flexible dosage options provided. Since Orilissa has already been on the market for three years and Phase III data has been published for relugolix, ObsEva risks receiving a smaller market share upon Yselty’s release.
Bundra continues: “Factors that could bolster Yselty’s success include minimal side effects (BMD loss and hormonal flares), multiple dosage options, and longevity of potential use. Orilissa (200mg), on the other hand, can only be taken for up to six months, which can be problematic for a chronic condition like endometriosis.
“AbbVie currently enjoys a market free from GnRH antagonist competition, although that will likely change once relugolix finishes development. Yselty’s capacity to compete will be largely dictated by the EDELWEISS 3 Q4 2021 data readout.”
*Includes endometriosis therapies in development by pharma companies, government bodies and institutions from the Pre-clinical stage to Phase III development.