FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC)
The committee discussed a biologics license application (BLA) for Evenity (romosozumab) injection, submitted by Amgen, for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant of other available osteoporosis therapy.. A majority of the committee, 16of 19 members, voted that the overall benefit/risk profile of romosozumab is acceptable to support approval for the proposed osteoporosis use.
The Committee did not support, by a vote of 6-Yes to 13-No, with no abstentions, the safety and efficacy of Tlando (oral testosterone undecanoate capsules), submitted by Lipocine Inc. (Lipocine) for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The Committee did not support, by a vote of 9-Yes to 10-No, with no abstentions, the safety and efficacy of Jatenzo (oral testosterone undecanoate capsules),submitted by Clarus Therapeutics, Inc. (Clarus) for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The Committee discussed appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The Committee also discussed whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions.
The Committee dicussed appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis
The Committee supported, by a vote of 14-Yes to 4-No, with no abstentions, the safety and efficacy of desmopressin nasal spray, submitted by Serenity Pharmaceuticals, LLC (Serenity). However, the Committee members who supported approval felt that the sponsor’s proposed indication, the treatment of adult onset nocturia, was too broad, and they instead preferred a narrower indication (e.g., adult nocturnal polyuria).
The Committee was scheduled to discuss an NDA for,enclomiphene citrate, 12.5 milligram (mg) and 25 mg capsules, submitted by Repros Therapeutics, Inc., (Repros) for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/milliliter (ml), younger than 60 years of age with a Body Mass Index (BMI) over 25 kilograms (kg)/meters squared (m2).
This meeting was cancelled. The FDA stated that they no longer needed the outside, expert advice. Repros says the cancellation was due to questions regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data.
The Committees jointly supported approval of Addyi (flibanserin 100 mg tablets) by Sprout Pharmaceuticals Inc. (Sprout) for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. In particular, 18 members voted “Yes, but only if certain risk management options beyond labeling are implemented.” Six members voted “No.” There were no votes for the other option, “Yes, with labeling alone to manage the risks.”
Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC)
BRUDAC reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of obstetrics, gynecology, and related specialties, and makes appropriate recommendations to the Commissioner of Food and Drugs.