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ObsEva (OBSV) Files NDA for Linzagolix to Treat Uterine Fibroids

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ObsEva SA (OBSV - Free Report) announced that it has submitted a new drug application (“NDA”) to the FDA for its investigational oral GnRH receptor antagonist, linzagolix, for the treatment of uterine fibroids.

The NDA is based on data from two phase III studies, PRIMROSE 1 and PRIMROSE 2, which evaluated the safety and efficacy of linzagolix in patients with heavy menstrual bleeding (“HMB”) associated with uterine fibroids. During the 52-week treatment period, the patients were administered linzagolix in two dosing regimens of 100 mg and 200 mg once daily, with and without hormonal add-back therapy. Both the studies achieved their primary endpoints, as linzagolix significantly reduced HMB in comparison to placebo.

Please note that the data from the phase III studies was supported by data from the 76-week post-treatment follow-up study.

In the year so far, ObsEva’s stock price has risen 44.7% against the industry’s 1.2% decline.

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Uterine fibroids are common non-cancer tumors that grow on the uterus’ muscular tissue. Mainly affecting women of childbearing age, uterine fibroids are characterized by wide-ranging symptoms including HMB, anemia, pelvic pressure and bloating, urinary frequency, and extreme pain that can significantly impact the quality of life as well as mental health.

The dearth of long-term treatments for the indication makes hysterectomies the only viable option. Per the company, approximately 300,000 hysterectomies for uterine fibroids are performed in the United States alone each year.

With its potential approval in the United States, linzagolix will be the first oral GnRH antagonist to provide therapeutic alternatives for women who are unable to take hormone therapy. The drug will also become the company’s first marketable drug following approval.

It is to be noted by investors that the company has already received validation of the marketing authorization application in the EU for a similar indication. The company anticipates approval recommendation from the Committee for Medicinal Products for Human Use in fourth-quarter 2021.

Linzagolix is also being evaluated in a phase III EDELWEISS 3 study for the treatment of pain associated with endometriosis. Top-line data from the study is anticipated in fourth-quarter 2021.

We remind investors that ObsEva acquired the in-license rights of linzagolix from Japan-based pharma company Kissei in 2015. The rights also include global (excluding Asia) commercial rights for the product.

AbbVie’s (ABBV - Free Report) elagolix has been approved by the FDA for the treatment of both HMB reduction in uterine fibroids and pain associated with endometriosis under the trade names Oriahnn and Orilissa, respectively.

Zacks Rank & Stocks to Consider

ObsEva currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the same sector include Regeneron Pharmaceuticals (REGN - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) , each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates for 2021 have increased from $49.43 to $53.22 in the past 60 days. The same for 2022 has risen from $41.35 to $44.84 over the same period. The stock has rallied 33.6% in the year so far.

Vertex’s earnings per share estimates for 2021 have increased from $11.22 to $12.37 in the past 60 days. The same for 2022 has risen from $12.26 to $13.13 over the same period.