FDA Takes Step Forward on Testosterone Therapy for Men
The FDA is encouraging sponsors of approved testosterone replacement therapy products to contact the agency for information regarding the pursuit of a new indication for low libido in men with idiopathic hypogonadism.
This affects manufacturers of FDA-approved testosterone replacement therapies and their associated regulatory, clinical, and medical affairs departments.
This signal suggests a potential shift in the agency's willingness to consider libido-specific indications within the context of idiopathic hypogonadism. Historically, testosterone indications have been tightly controlled; this invitation for dialogue may indicate a framework for expanding therapeutic claims or a standardized approach to the clinical data required to support such an indication. Regulatory teams may find this an opportunity to seek formal guidance on clinical endpoints and labeling requirements for a secondary symptom-based indication.
Sponsors with existing testosterone approvals should evaluate clinical data regarding low libido in idiopathic hypogonadism and contact the FDA to discuss the requirements for a supplemental New Drug Application (sNDA). Regulatory teams should prepare for potential pre-submission meetings to clarify data expectations for this specific indication.
FDA is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement therapy products to contact FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism.
Open in openFDA / FDA.gov