Dive Brief:
- Repros Therapeutics' enclomiphene will face a U.S. Food and Drug advisory committee on December 6. The drug was rejected in December 2015 and Repros has since conducted more studies to help support its new drug application. Advisory committee decisions are not binding, but the FDA often follows its recommendation.
- The FDA’s Bone, Reproductive and Urologics Drug Advisory Committee is expected to discuss clinical trial design features to treat secondary hypogonadism involving the pituitary gland, while preserving or improving testicular function. Secondary hypogonadism, often associated with obesity, is among the most common causes of low testosterone in men and is estimated to impact 13 million men in the U.S.
- Repros is trying to separate itself from a cascade of drugmakers which have entered the space over the years, amid controversy involving over-prescribing and safety issues of medications for low-testosterone.
Dive Insight:
A year after Repros announced the FDA had canceled its first advisory committee meeting for the drug, the biotech revealed that questions persist and it will now face expert scrutiny. Enclomiphene initially had a target action date of November 30, 2015, but that date was pushed back after the company reached an agreement to work with the agency on outstanding questions about the product.
An advisory committee meeting in September 2014 questioned the use of products for the treatment of low-T and pushed for use of these products in only certain populations. Experts argue the underlying causes of low-T should be treated before patients are given drugs for the issue.
Enclomiphene, under development, is a single isomer of clomiphene citrate and an orally active propriety small molecular medication.
"We believe that by treating the cause of secondary hypogonadism, enclomiphene, also has the potential to maintain reproductive status and potentially improve overall metabolic profiles," the company said in a statement.
This month, Repros’s UK subsidiary, Renable Pharma Ltd. submitted marketing approval for the drug with the European Medicines Agency (EMA). In a statement following that application, Fred Wu, a principal investigator in a European Male Aging Study, said low testosterone (secondary hypogonadism) is "one of the most disabling but less recognized problems in obese men."
Repros said it continues to consider investigate enclomiphene as an adjuvant therapy in hypogonadal men with type 2 diabetes. According to the company, research has established that increased insulin resistance, implicated in Type 2 diabetes, is associated with the onset of secondary hypogonadism.