FDA Approves Expanded Use of Lilly's FORTEO(R) [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporos
24 July 2009 - 12:44AM
PR Newswire (US)
First and only FDA-approved anabolic agent in the U.S. now
indicated to treat the leading type of secondary osteoporosis
INDIANAPOLIS, July 23 /PRNewswire-FirstCall/ -- Today, Eli Lilly
and Company (NYSE:LLY) announced that the U.S. Food and Drug
Administration (FDA) has approved a new use for its osteoporosis
drug FORTEO [teriparatide (rDNA origin) injection] to treat
osteoporosis associated with sustained, systemic glucocorticoid
therapy in men and women at high risk of fracture. Glucocorticoid
therapy is the most common cause of secondary osteoporosis, leading
to bone loss and an increased risk for fracture.(1) "Patients who
take long-term glucocorticoid therapy are already dealing with a
serious health condition, and, on top of that, they may be at a
significantly higher risk for fracture," said Vladimir Kopernicky,
medical director for Eli Lilly and Company. "The FDA's decision
provides these patients with a valuable treatment option for
osteoporosis, which they may develop as a result of their sustained
glucocorticoid use." Glucocorticoid-induced osteoporosis, or GIO,
is associated with chronic use of glucocorticoid medications, which
are often prescribed for inflammatory conditions such as rheumatoid
arthritis and obstructive pulmonary disease. Data indicate that
glucocorticoid medications are used by up to three out of every 100
adults over age 50. (2) Approximately 50 percent of individuals who
are prescribed chronic glucocorticoid therapy will eventually have
an osteoporotic fracture.(3) The use of glucocorticoid medications
can lead to a reduction in bone formation.(4) FORTEO has been shown
to counter this effect by stimulating bone formation.(5) In the
course of the FDA's review of the new indication, Lilly provided
data from a clinical study which showed that in patients with
glucocorticoid-induced osteoporosis, FORTEO increased bone mineral
density (BMD) from baseline to 18 months of treatment by 7.2
percent at the lumbar spine, 3.6 percent at the total hip, and 3.7
percent at the femoral neck.(5) "Until now, physicians and patients
had only one class of approved therapy for the treatment of
glucocorticoid-induced osteoporosis," said Kenneth G. Saag, M.D.,
MSc, professor of medicine and epidemiology at the University of
Alabama in Birmingham. "The approval of teriparatide for this new
indication offers healthcare providers and patients a new treatment
option that effectively increases bone mineral density in a
different way than anti-resorptives." Label Updates Since this new
indication extends the use of FORTEO to patients with GIO who may
be younger than those currently receiving the medication, Lilly has
updated the language in the existing boxed warning section of the
label regarding the risk of osteosarcoma to reinforce that FORTEO
should not be used in pediatric and young adult patients whose
bones are still growing. In addition, due to the increased patient
population, Lilly established a voluntary FORTEO Patient Registry
to further evaluate the long-term safety of FORTEO. Osteosarcoma is
a serious but rare cancer which occurs at a rate of about four
cases per million people, per year. Osteosarcoma has been reported
rarely in people who took FORTEO. It is not known if people who
take FORTEO have a higher chance of getting osteosarcoma. About
FORTEO FORTEO is also indicated for the treatment of osteoporosis
in postmenopausal women who are at high risk for fracture and to
increase bone mass in men with primary or hypogonadal osteoporosis
who are at high risk for fracture.(6) FORTEO is the first
osteoporosis therapy approved by the U.S. Food and Drug
Administration (FDA) that actually rebuilds bone.(7) Since
receiving FDA approval in November 2002, more than 3.1 million
prescriptions for FORTEO have been filled in the United States.(8)
Important Safety Information about FORTEO During the drug testing
process, the medicine in FORTEO caused some rats to develop a bone
cancer called osteosarcoma. In people, osteosarcoma is a serious
but rare cancer. Osteosarcoma has been reported rarely in people
who took FORTEO. It is not known if people who take FORTEO have a
higher chance of getting osteosarcoma. You should not take FORTEO
for more than 2 years over your lifetime. There is a voluntary
Patient Registry for people who take FORTEO. The purpose of the
registry is to collect information about the possible risk of
osteosarcoma in people who take FORTEO. For information about how
to sign up for this patient registry, call 1-866-382-6813 or go to
http://www.forteoregistry.rti.org/. Do not use FORTEO if you are
allergic to any of the ingredients in FORTEO. Before you take
FORTEO, you should tell your healthcare provider if you have
Paget's disease or other bone disease; have cancer in your bones;
have trouble injecting yourself and do not have someone who can
help you; are a child or young adult whose bones are still growing
or have or have had kidney stones; if you have had radiation
therapy; have or had too much calcium in your blood; have any other
medical conditions; or take medications that contain digoxin
(Digoxin, Lanoxicaps, Lanoxin). Please consult your healthcare
provider if you are pregnant or thinking about becoming pregnant.
It is not known if FORTEO will harm your unborn baby. If you are
breast-feeding or plan to breast-feed, it is not known if FORTEO
passes into your breast milk. You and your doctor should decide if
you will take FORTEO or breast feed. You should not do both. FORTEO
can cause serious side effects including an increase in blood
pressure when you change positions. Some people feel dizzy, get a
fast heartbeat, or feel faint right after the first few doses. This
usually happens within 4 hours of taking FORTEO and goes away
within a few hours. For the first few doses, take your injections
of FORTEO in a place where you can sit or lie down right away if
you get these symptoms. If your symptoms get worse or do not go
away, stop taking FORTEO and call your healthcare provider. Serious
side effects also include increased calcium in your blood. Tell
your healthcare provider if you have nausea, vomiting,
constipation, low energy, or muscle weakness. These may be signs
there is too much calcium in your blood. Common side effects of
FORTEO include nausea, joint aches, pain, leg cramps, and injection
site reactions such as redness, swelling, pain, itching, a few
drops of blood, and bruising. These are not all the possible side
effects of FORTEO. The FORTEO delivery device has enough medicine
for 28 days. It is set to give a 20 microgram dose of medicine each
day. Do not inject all the medicine in the FORTEO delivery device
at any one time. Inject FORTEO one time each day in your thigh or
abdomen (lower stomach area). Talk to a healthcare provider about
how to rotate injection sites. Do not transfer the medicine from
the FORTEO delivery device to a syringe. This can result in taking
the wrong dose of FORTEO. If you do not have pen needles to use
with your FORTEO delivery device, talk with your healthcare
provider. If you take more FORTEO than prescribed, call your
healthcare provider. If you take too much FORTEO, you may have
nausea, vomiting, weakness or dizziness. Keep your FORTEO delivery
device in the refrigerator between 36 degrees to 46 degrees F (2
degrees to 8 degrees C). Do not freeze the FORTEO delivery device.
Do not use FORTEO if it has been frozen. Do not use FORTEO after
the expiration date printed on the delivery device and packaging.
Throw away the FORTEO delivery device after 28 days even if it has
medicine in it (see the User Manual). For more information about
FORTEO, including full prescribing information, visit
http://www.forteo.com/. About Lilly Lilly, a leading
innovation-driven corporation, is developing a growing portfolio of
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers -- through medicines and information -- for
some of the world's most urgent medical needs. Additional
information about Lilly is available at http://www.lilly.com/.
P-LLY Forward Looking Statement This press release contains
forward-looking statements about the safety and efficacy of FORTEO
and reflects Lilly's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
There is no guarantee that FORTEO will continue to be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements. (1) Trends Endocrinol. 2006; 17:
144-149. (2) Clin Rheumatol. 2007; 26: 144-153. (3) Endocrinol
Metab Clin North Am. 2003; 32: 135-157. (4) Van Staa, TP "The
Pathogenesis, Epidemiology and Management of Glucocorticoid-Induced
Osteoporosis," Calcif Tissue Int. 2006; 79:129-137. (5) N Engl J
Med. 2007; 357:2028-39. (6) FORTEO Prescribing Information. (7)
Curr Opin Orthop. 2003; 14:438-439. (8) Data on file, Lilly
Research Laboratories (FOR20081217A). (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGODATASOURCE: Eli
Lilly and Company CONTACT: Teresa Shewman of Eli Lilly and Company,
Office: +1-317-433-1888, or Mobile: +1-317-292-8940,
Copyright