Repros Therapeutics Inc. announced that the European Medicines Agency has accepted for review its marketing authorization application for enclomiphene. The company is looking to get enclomiphene approved for the treatment of secondary hypogonadism.
Repros expects to receive day 120 questions related to the application by the end of Jan 2017.
We remind investors that Repros’ efforts to gain approval for enclomiphene in the U.S. for the treatment of secondary hypogonadism had suffered a setback with the FDA issuing a complete response letter in Dec 2015. Currently, the company is conducting a proof-of-concept phase II study (ZA-205) on enclomiphene in obese secondary hypogonadal men to assess its impact on metabolic parameters and quality of life with routine diet and exercise regimen. Six-month interim data from this study were reported in Aug 2016.
Repros plans to participate as a sponsor in the upcoming FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee meeting. The meeting is scheduled for Dec 6, 2016. The committee intends to discuss appropriate clinical trial design features, including acceptable endpoints for establishing clinical benefit, for drugs that are intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis.
REPROS THERAPEU Price
Meanwhile, Repros has made significant progress with its pipeline so far, which includes Proellex. The company plans to hold discussion with the FDA regarding the prospects of advancing the candidate into phase III studies for the treatment of women struggling with painful menstruation. In addition, Proellex is being evaluated for the treatment of uterine fibroids.
The latest development on the regulatory front raises optimism. Considering that Repros has no approved product in its portfolio at the moment, enclomiphene’s approval will be a huge boost for the company.
Investor focus is expected to remain on the upcoming FDA advisory panel meeting as well on EU updates on the candidate.
Currently available treatments for hypogonadism in the market include AbbVie Inc.’s (ABBV - Free Report) AndroGel, Endo International plc’s (ENDP - Free Report) Testim and Allergan plc’s (AGN - Free Report) Androderm.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>