FDA approves supplemental new drug application for Abbott's Lupron Depot-PED

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

Abbott said the FDA approved its sNDA for Lupron Depot-PED (leuprolide acetate) for depot suspension, saying the one-month formulation was the first product in its class to include long-term data in its label for the treatment of central precocious puberty, or CPP, which causes children to enter puberty too soon. The prescribing information now includes 19 years of data, including prespecified outcome results on puberty, height and reproductive function.

Abbott's application included data from an open-label study that enrolled 55 patients between the ages of 5 years and 9 years in a treatment phase. Patients were assessed for signs and symptoms of puberty, a hormone called LH and reproductive function. During treatment, Abbott said, puberty was suppressed and normalized growth rates were achieved.

"Guiding a child through puberty can be a challenge for any parent, but when things go awry in the body and this process happens too soon, it can be worrisome for everyone," Abbott SVP global pharmaceutical research and development John Leonard said. "This study provides patients and physicians with important information to better understand Lupron Depot-PED for one-month administration and its long-term impact, particularly on reproductive function and normalized adult height."

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