FDA OKs puberty drug treatment
NEWS-SUN STAFF REPORT August 25, 2011 10:04PM
Updated: August 26, 2011 2:34AM
ABBOTT PARK — The Food and Drug Administration has approved two three-month strengths of Abbott Laboratories’ Lupron Depot-PED to treat children with central precocious puberty, a condition that causes young children to start puberty too soon.
Lupron Depot-PED works by suppressing the level of hormones that cause puberty, helping delay premature puberty in girls under 8 and boys under 9 until a more appropriate time in the child’s life. With the approval of a three-month formulation, children with CPP now may receive their treatment four times per year instead of 12.
“The approval of two new three-month depot strengths of Lupron Depot-PED is important because it adds additional treatment options for children with CPP and may reduce the number of injections per year from 12 to four,” said Dr. Eugene Sun, vice president, of Abbott’s Global Pharmaceutical Development.
Abbott’s submission to the FDA was supported by new data from a 24-week, open-label study involving 84 patients with central precocious puberty.
Abbott announced today that the first patient in Japan has been treated with the ABSORB bioresorbable vascular scaffold (BVS) as part of the ABSORB EXTEND clinical trial. ABSORB is an innovative therapy that restores blood flow by opening a clogged vessel and providing support to the vessel until the device dissolves within approximately two years, leaving patients with a treated vessel free of a permanent metallic implant.