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Abbott drug approved for precocious puberty

Abbott has received FDA approval for two new strengths of Lupron Depot-PED three-month administration for the treatment of central precocious puberty (CPP)
Abbott has received approval from the US Food and Drug Administration (FDA) for two new strengths of three-month administration of Lupron Depot-PED (leuprolide acetate for depot suspension) for the treatment of children with central precocious puberty (CPP). 

Lupron Depot-PED is a gonadotropin-releasing hormone (GnRH) agonist, which (after regular use) prevents the pituitary gland from releasing luteinising hormone (LH) and follicle stimulating hormone (FSH), the hormones that cause puberty. Suppressing these hormones allows the development of secondary sex characteristics to be arrested until a more appropriate time in a child's life. 

Lupron Depot-PED is already approved (at three separate dose strengths of 7.5mg, 11.25mg and 15mg) to treat CPP by monthly administration, as well as for the treatment of prostate cancer in adult men and endometriosis and uterine fibroids in adult women. 

The new approval for three-monthly administration (at the two doses of 11.25mg and 30mg) means that children being treated with Lupron Depot-PED could potentially reduce their number of the physician-administered injections from 12 per year to four, giving the patients greater freedom.

The FDA's decision to approve the three-month administration doses was supported by data from a 24-week, open-label study of 84 CPP patients, who were treated with two injections 12 weeks apart. Over six months of follow-up, hormone suppression was found to be sustained over the three-month period. 

Lupron was initially marketed by TAP Pharmaceuticals, a joint venture between Abbott and Takeda. However, in the US in 2001, TAP paid $875m to settle the serious criminal and civil charges it faced in connection with its fraudulent drug pricing and marketing conduct with regard to Lupron. The joint venture was dissolved in 2008, and Abbott took over the marketing of Lupron.

Other treatments for CPP include Endo Pharmaceuticals' GnRH-agonist Vantas/Supprelin LA (histrelin acetate), which is available as a 12-month subcutaneous implant. Another GnRH-agonist, triptoreline, is marketed by Ipsen as Decapeptyl, by Ferring Pharmaceuticals as Diphereline and Gonapeptyl, and by Watson as Trelstar. Additionally, CPP may be treated by off-label usage of AstraZeneca's oral aromatase-inhibitor Arimidex (anastrazole), which is indicated for the treatment of breast cancer.  

The three-month formulations of Lupron Depot-PED are anticipated to be available later this month.

17th August 2011

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