Abbott Laboratories
Abbott Seeks FDA Approval of a New Six-Month 45-mg Formulation of Lupron®
Depot for the Palliative Treatment of Advanced Prostate Cancer
March 11, 2010
Abbott Park, Illinois (NYSE: ABT) -- The U.S. Food and Drug
Administration(FDA) has accepted for review the supplemental new drug
application (sNDA) of a new six-month 45-mg formulation of Lupron®
Depot (leuprolide acetate for depot suspension) for use in the
palliative treatment of advanced prostate cancer. Palliative treatment
helps to relieve symptoms associated with advanced prostate cancer.
Lupron Depot works by suppressing the production of the hormone
testosterone. This decrease in testosterone, which helps slow or stop
the growth of hormone-dependent cancer cells, may relieve pain and
other symptoms related to advanced prostate cancer.
"For many patients with advanced prostate cancer, Lupron Depot is an
important treatment option because it can help manage the symptoms of
their disease," said Eugene Sun, M.D., vice president, Global
Pharmaceutical Development, Abbott. "Abbott is seeking approval for a
new six-month formulation to provide greater convenience and dosing
flexibility to physicians and patients who could benefit from this
medication."
Lupron Depot is currently available in one-month (7.5 mg), three-month
(22.5 mg) and four-month (30 mg) depot formulations. Abbott's
submission is supported by new data from a 48-week study involving 300
patients with prostate cancer. Patients received a total of two
injections, 24 weeks apart, and were followed for nearly one year to
evaluate efficacy and safety. Overall, testosterone suppression with
this new 45-mg six-month depot formulation was sustained in patients
throughout the treatment period. The onset of testosterone suppression
was consistent with other currently available Lupron Depot
formulations.
About Prostate Cancer
This year in the U.S., approximately 200,000 new cases of prostate
cancer will be diagnosed. Prostate cancer is the most common type of
cancer diagnosed in American men. More than 70 percent of all prostate
cancers are diagnosed in men older than 65, and one in six men will be
diagnosed with prostate cancer in their lifetime.
For additional information on Lupron Depot for the palliative
treatment of advanced prostate cancer, visit
www.prostate.com.
Full Prescribing Information for Lupron Depot 7.5 mg is available at
www.rxabbott.com/pdf/lupron7_5mg.pdf
Full Prescribing Information for Lupron Depot three-month 22.5 mg is
available at
www.rxabbott.com/pdf/lupron3month22_5mg.pdf
Full Prescribing Information for Lupron Depot four-month 30 mg is
available at
www.rxabbott.com/pdf/lupron4month30mg.pdf
About Lupron Depot
Lupron Depot belongs to a class of medications known as gonadotropin
releasing hormone agonists (GnRHa). Lupron was first approved for
subcutaneous injection in 1985 and was supported by results from
clinical trials which demonstrated the efficacy and safety from daily
injections. Lupron Depot 7.5 mg was approved in 1989 followed by
Lupron Depot three-month (22.5 mg) and Lupron Depot four-month (30
mg).
Use
Lupron Depot® (leuprolide acetate for depot suspension) 7.5 mg,
three-month 22.5 mg and four-month 30 mg are prescribed for the
palliative treatment of advanced prostate cancer.
Important Safety Information
Do not take Lupron Depot if any type of allergic reaction to Lupron
Depot or similar drugs has been experienced.
Lupron Depot 7.5 mg, - three-month 22.5 mg and - four-month 30 mg
should not be used in women.
An increase in testosterone will generally occur during the first few
weeks of therapy. In some men, this may cause a temporary increase in
urinary symptoms and/or pain. Men with cancer that has spread to the
spine or urinary tract may require close medical attention during the
first few weeks of therapy. Men should also know that Lupron Depot may
cause impotence.
The doctor should be notified if any new or worsened symptoms develop
after beginning Lupron Depot treatment.
It is recommended that men have their PSA and serum testosterone
levels monitored at regular intervals.
The most common side effects of Lupron Depot include hot flashes or
sweats, injection site reactions, general pain, edema, testicular
atrophy, urinary disorders, joint disorders and GI disorders.
Lupron Depot must be administered in the doctor's office.
This is the most important information to know about Lupron Depot. For
more information, talk with a health care provider.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company
devoted to the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals, devices
and diagnostics. The company employs more than 72,000 people and
markets its products in more than 130 countries.
Media:
Julie Herlocker
(847) 936-6116
Financial:
Lawrence Peepo
(847) 935-6722
