FDA approve two three-month strengths of Lupron Depot-PED® (leuprolide acetate for depot suspension)

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved two new strengths for three-month administration of Lupron Depot-PED ® (leuprolide acetate for depot suspension) for the treatment of children with central precocious puberty (CPP). CPP is a condition that causes children to enter puberty too soon, resulting in the development and progression of secondary sex characteristics such as breast development in females and genital development in both males and females, and can potentially lead to a diminished adult height. By definition, CPP starts in girls under the age of 8 and boys under the age of 9. Treatment with Lupron Depot-PED helps to arrest pubertal development until a more appropriate time.

“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 Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.

Patients with central precocious puberty who have been prescribed Lupron Depot-PED receive an injection that is administered in the physician office. The three current strengths of Lupron Depot-PED are given to patients once a month. Now, patients who are prescribed the newly approved formulation may receive their treatments every three months.

Lupron Depot-PED works by suppressing the level of hormones that cause puberty. This decrease in the production of certain hormones delays premature puberty until a more appropriate time in the child’s life.

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. Patients received a total of two injections, 12 weeks apart, and were followed for nearly six months to evaluate hormone suppression and safety. Overall, hormone suppression with the new three-month depot formulation in both strengths was sustained in patients throughout the treatment period. In patients who had not been previously treated for CPP, the onset of hormone suppression was consistent with other currently available Lupron Depot-PED formulations. ;The most common side effects from this study were injection-site pain, weight gain, headache, altered mood and injection-site swelling. The three-month formulation is expected to be available in late August.

About Central Precocious Puberty

Central precocious puberty is a condition in which puberty starts too early in children. This occurs in one child of every 5,000 to 10,000 children and is more common in girls.

During puberty, the brain produces a hormone called gonadotropin-releasing hormone (GnRH). Through a complex process, GnRH causes increases in other hormones like luteinizing hormone (LH) and follicle stimulation hormone (FSH). It is these hormones that cause the ovaries to produce estrogen and the testicles to produce testosterone.

With central precocious puberty, girls under the age of 8 and boys under the age of 9 begin to develop signs of puberty.

For additional information on Lupron Depot-PED for the treatment of central precocious puberty, visit www.lupronped.com.

Use for Lupron Depot-PED® (leuprolide acetate for depot suspension)

Lupron Depot-PED 7.5 mg, 11.25mg and 15mg for 1-month and 11.25mg and 30mg for 3-month administration are prescribed for the treatment of children with central precocious puberty (CPP).

Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. The doctor should perform tests to rule out possible causes of CPP that would require different treatment (e.g., tumors).

Important Safety Information for Lupron Depot-PED

Children should not receive any formulation of Lupron Depot-PED if they have experienced any type of allergic reaction to Lupron Depot-PED or similar drugs.

Females who are or may become pregnant should not receive any formulation of Lupron Depot-PED.

During the first weeks of Lupron Depot-PED treatment, signs of puberty, such as vaginal bleeding, may occur. This is a common initial effect of the drug. The doctor should be notified if signs/symptoms of puberty continue beyond the second month of treatment.

Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in patients who are taking medications that have been associated with convulsions. Convulsions have also been reported in patients without any of these conditions.

The initial response to Lupron Depot-PED should be monitored, as well as the continued response during treatment, as clinically needed. For children receiving a 1-month injection, response is assessed 1-2 months after the initial injection. For children receiving a 3-month injection, response is assessed 2-3 months after the initial injection and month 6. Height and bone age should be checked every 6-12 months in children using Lupron Depot-PED.

It is important that children keep their doctor appointments and follow the prescribed injection schedule. Pubertal development could begin again if injections are missed.

The most common side effects for any GnRH agonist, including Lupron Depot-PED, are injection site reactions/pain including abscess, general pain, headache, fluctuating emotions, and hot flushes/sweating.

The most frequent adverse reactions in Lupron Depot-PED studies were pain; acne; injection site reactions, including pain, swelling and abscess; rash, including a painful rash with fever, blisters/sores, and facial swelling; vaginitis/vaginal bleeding/vaginal discharge; increased weight; and altered mood.

After the injection, some pain and irritation is expected; however, if more severe symptoms occur or if any new, unusual, or worsened symptoms develop, the child’s doctor should be contacted.

Lupron Depot-PED is not for children under 2 years of age.

Lupron Depot-PED must be administered under the supervision of a physician.

For more information, talk with a health care provider.

Full prescribing information for Lupron Depot-PED is available at http://www.rxabbott.com/pdf/lupronpediatric.pdf