The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has repeated its positive review of Obseva SA’s (NASDAQ: OBSV) Linzagolix. The company developed the drug to treat uterine fibroids.
The first positive review came in December 2021, while the second came after the company applied for marketing authorisation. The E.U will consider the review as it makes its authorisation decision.
An approval could mean that Linzagolix would be the first oral Gonadotropin-Releasing Hormone (GnRH) antagonist that gives choice and flexibility to uterine fibroids patients. It would also be the only non-hormonal therapy for patients with the disease who won’t or can’t use hormone therapy.
The company is partnering with Theramex to sell the drug
Any decision the E.U will come to will apply to member states, Liechtenstein, Iceland, and Norway. Meanwhile, the company and Theramex have made a deal to facilitate the drug’s commercialisation and marketing in Europe.
Theramex is the ideal partner as it has over 180 representatives in Europe, Australia, and Brazil. It also uses third-party distributors in more than 60 Middle Eastern, Latin American, Asia Pacific, African, and European countries.
According to ObsEva’s CEO, Brian O’Callaghan, the company is preparing to launch Linzagolix in Europe as it awaits E.U approval. Theramex, which is among the top companies globally that are involved in women’s health, could ensure the success of the launch.
The company hopes to launch the drug in the U.S
He adds that the company will also launch the product in the U.S through its partnership with Syneos Health Inc (NASDAQ: SYNH). The company hopes to leverage these agreements to ensure a successful launch of Linzagolix. Moreover, U.S FDA is currently reviewing a New Drug Application for the compound.
The company developed Linzagolix as an oral therapy to be taken at one dose daily for patients with uterine fibroids. ObsEva made the drug for patients to take with hormonal therapy or alone. This drug offers women flexibility as they can choose whether or not to use hormone therapy. It is also safe to use and tolerable. The company is now evaluating the efficacy and safety of the drug for patients with endometriosis.
ObsEva is a company that develops drugs for women’s pregnancy and reproductive health issues.
