Abbott Laboratories (ABT) recently announced that the US Food and Drug Administration (FDA) approved two new strengths of Lupron Depot-PED (leuprolide acetate for depot suspension) for the treatment of children with central precocious puberty (CPP). These new strengths are for three-month administration.
CPP causes children to enter puberty early in life, resulting in the development and progression of secondary sex characteristics such as breast development in females and genital development in both males and females, resulting in shorter height. The disorder starts in girls under the age of 8 and boys under the age of 9.
Lupron Depot-PED helps suppress the level of hormones among children that cause puberty. This decrease in the production of certain hormones delays premature puberty.
Abbott Labs’ application to the FDA was based on data from a 24-week study involving 84 patients with CPP. In the study, the patients received two injections, 12 weeks apart. The patients were followed for nearly six months to evaluate hormone suppression and safety. Results from the study revealed that hormone suppression with the new three-month depot formulation in both strengths was sustained in patients throughout the duration of the therapy.
We note that Lupron Depot-PED 7.5 mg, 11.25 mg and 15 mg for one-month and 11.25 mg and 30 mg for three-month administration are currently prescribed for the treatment of children with CPP.
We currently have a Neutral recommendation on Abbott Labs. The stock carries a Zacks #3 (Rank) in the short-run that translates into a Hold rating. We view this approval as a positive for the company, which also markets Lupron as a treatment for advanced prostate cancer, and for the pre-operative treatment of patients with anemia caused by uterine fibroids.
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