FDA Issues Draft Guidance on Drugs for Treatment of Acromegaly

Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or exposure-response based on insulin-like growth factor 1 (IGF-1) levels in early-phase trials, the FDA said in a draft guidance released Monday.

Acromegaly, which is caused by a benign tumor on the pituitary gland that can lead to overproduction of IGF-1, results in a range of conditions, including bone and tissue overgrowth, diabetes, hypertension, fatigue, weakness, excessive perspiration, joint pain, edema, sleep apnea and excessive snoring.

The first-line treatment for the disease is tumor removal, while the second-line therapy includes radiotherapy and medications that reduce IGF-1 secretion in the body.

Comments on the draft must be submitted by March 31.