![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Issues Draft Guidance on Drugs for Treatment of Acromegaly
FDA Issues Draft Guidance on Drugs for Treatment of Acromegaly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and/or exposure-response based on insulin-like growth factor 1 (IGF-1) levels in early-phase trials, the FDA said in a draft guidance released Monday.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.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct