INDIANAPOLIS, April 4, 2008 – Eli Lilly and Company
(NYSE: LLY) today announced that the European Commission has approved a new
indication for FORSTEO(R) (teriparatide [rDNA origin] injection) for the
treatment of osteoporosis associated with sustained, systemic
glucocorticoid therapy in women and men at increased risk for fracture.
This approval follows the initial positive opinion issued in February by
the Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Evaluation Agency (EMEA).
Teriparatide stimulates new bone formation by increasing the number and
action of bone-building cells called osteoblasts. Teriparatide, originally
authorized for marketing in 2003 for the treatment of osteoporosis in
postmenopausal women at high risk for fracture, received an expanded
indication for the treatment of osteoporosis in men at increased risk for
fracture in 2007.
“Chronic glucocorticoid therapy is the most common cause of secondary
osteoporosis, often leading to bone loss and an increased risk for
fracture,” said Gwen Krivi, Ph.D., vice president of Lilly Research
Laboratories. “We are pleased with the European Commission’s decision to
approve teriparatide for this new use.”
Glucocorticoid-induced osteoporosis, or GIOP, is bone loss associated
with chronic use of glucocorticoid medications. These medications are often
prescribed for inflammatory conditions, such as rheumatoid arthritis and
obstructive pulmonary disease. Globally, an estimated one to three percent
of adults over the age of 50 use glucocorticoids. (1)
“Up to 50 percent of individuals on chronic glucocorticoid therapy will
develop bone loss leading to an osteoporotic fracture,”(2) said Dr. Steven
Boonen, professor of medicine at the Leuven University Centre for Metabolic
Bone Diseases in Belgium. “This new indication for teriparatide provides
physicians and patients with a new treatment option that builds bone.”
The submission package to support the safety and efficacy profile of
teriparatide included new data from the “Teriparatide or Alendronate in
Glucocorticoid-Induced Osteoporosis” study, which was published in the
November 15, 2007 issue of the New England Journal of Medicine. This
head-to- head comparative study showed that in patients with
glucocorticoid-induced osteoporosis, teriparatide significantly increased
lumbar spine bone mineral density (BMD) from baseline (7.2 percent)
compared to alendronate (3.4 percent) at 18 months of therapy.(3)
Information about Teriparatide
Teriparatide is the active fragment (1-34) of the human parathyroid
hormone and acts to stimulate bone formation by directly affecting bone
forming cells (osteoblasts), indirectly increasing the intestinal
absorption of calcium and increasing the re-absorption of calcium and
excretion of phosphate by the kidney. Teriparatide, marketed in the U.S.
since 2002, was first approved in the E.U. in 2003 for the treatment of
established osteoporosis in postmenopausal women who have an increased risk
As part of drug testing, teriparatide was given to rats for a
significant part of their lifetime. In these studies, teriparatide caused
some rats to develop osteosarcoma, a bone cancer. Osteosarcoma in humans is
a serious but very rare cancer. Osteosarcoma occurs in about four out of
every million older adults each year. It is not known if humans treated
with teriparatide also have a higher chance of getting osteosarcoma.
Teriparatide should be prescribed only to patients for whom the
potential benefits are considered to outweigh the potential risk. The drug
should not be prescribed for patients at increased baseline risk for
osteosarcoma, including patients with Paget’s disease of bone or
unexplained elevations of alkaline phosphatase, children or growing adults,
or those who have had prior external beam or implant radiation therapy
involving the skeleton. Additionally, patients with bone metastases or a
history of skeletal malignancies, and those with metabolic bone diseases
other than osteoporosis, should not receive teriparatide. Patients with
high levels of calcium in their blood should not receive teriparatide due
to the possibility of increasing their blood levels of calcium.
In clinical trials, the most frequent treatment-related adverse events
reported at the 20-microgram dose approved for marketing were mild, similar
to placebo and generally did not require discontinuation of therapy. The
most commonly reported adverse events in patients treated with teriparatide
are nausea, pain in limb, headache and dizziness.
Teriparatide is supplied in a disposable pen device that can be used
for up to 28 days to give once-daily self-administered injections.
Teriparatide is available in a 20-microgram dose and should be taken for a
period of up to 18 months. For full prescribing information, please visit
Osteoporosis is a debilitating disease that affects an estimated 75
million people in Europe, U.S. and Japan.(4) Osteoporosis, which means
“porous bone,” is a disease in which the density and quality of bone are
reduced. As the bones become more porous and fragile, the risk of fracture
is greatly increased. The loss of bone occurs “silently” and progressively
and no symptoms are apparent until the first fracture occurs.(5)
The most common fractures associated with osteoporosis occur at the
hip, spine and wrist. The incidence of these fractures, particularly at the
hip and spine, increases with age in both women and men.(6) Vertebral
fractures can result in serious consequences, including loss of height,
intense back pain and deformity.
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class 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.co.uk.
Forward Looking Statement
This press release contains forward-looking statements about the safety
and efficacy of teriparatide and reflects Lilly’s current beliefs. However,
as with any pharmaceutical product, there are substantial risks and
uncertainties in the process of research, development, and
commercialization. There is no guarantee that teriparatide for the
treatment of osteoporosis, including with glucocorticoid-induced
osteoporosis, 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) Clin Rheumatol. 2007; 26: 144-153
(2) Endocrinol Metab Clin N Am. 2003; 32; 135-157.
(3) N Engl J Med. 2007; 357:2028-39.
(4) International Osteoporosis Foundation. “Facts and statistics about
osteoporosis and its impact.” Available at http://www.iofbonehealth.org/facts-and–
statistics.html#factsheet-category-22. Accessed on February 8, 2008.
(5) International Osteoporosis Foundation. “What is
osteoporosis?” Available at http://www.iofbonehealth.org/patients–
Accessed on February 8, 2008. (6) International Osteoporosis
Foundation. “What is osteoporosis?”
Available at http://www.iofbonehealth.org/patients-public/about–
osteoporosis/what-is-osteoporosis.html. Accessed on February 8, 2008.
SOURCE Eli Lilly and Company