Home » Drug Information » FDA-Approved Drugs » 2002
Medical Areas: Endocrinology | Musculoskeletal | Obstetrics/Gynecology
View By: Year Company Therapeutic Areas Drug Names
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Eli Lilly
Approval Status: December 2002
Treatment Area: Osteoporosis
Forteo is a synthetic form of parathyroid hormone (PTH), which
is naturally found in the body. The synthetic hormone is to be
given by subcutaneous injection for the treatment of osteoporosis
in men and post-menopausal women who are at high risk for a
fracture.
Forteo is supplied in a disposable pen device that can be used
for up to 28 days to give once-daily self-administered injections.
Forteo is available in a 20 microgram (mcg) dose and should be
taken for a period of up to 24 months.
The FDA's approval of Forteo was based on 24 clinical trials
enrolling more than 2,800 postmenopausal women and men with
osteoporosis. Phase III clinical trial data showed that Forteo
stimulated new bone formation, lowered the risk of vertebral
(spinal) fractures and increased bone mineral density (BMD)
compared with placebo in postmenopausal women with osteoporosis
during an average of 19 months of treatment. The data also showed
that Forteo reduced the relative risk of spinal fractures by 65
percent (9.3 % absolute risk reduction), compared with placebo, and
lowered the relative risk of nonspinal fractures overall (sites
such as the wrist, ribs, hip, ankle/foot, etc.) by 53% (2.9%
absolute risk reduction), compared with placebo.
In addition, Forteo also significantly increased spine BMD in
postmenopausal women with osteoporosis beginning at three months of
treatment. The data showed that 96% of women had an increase from
baseline, with 72 percent achieving at least a 5 percent increase
in spine BMD and 44% gaining 10 percent or more compared with
placebo.
Adverse events associated with the use of Forteo (teriparatide)
may include (but are not limited to) the following:
- Pain
- Headache
- Asthenia
- Neck pain
- Hypertension
- Angina pectoris
- Syncope
- Nausea
- Constipation
- Dizziness
- Depression
- Insomnia
- Vertigo
Forteo [teriparatide (rDNA origin) injection] contains
recombinant human parathyroid hormone (1-34), [rhPTH(1-34)], which
has an identical sequence to the 34 N-terminal amino acids (the
biologically active region) of the 84-amino acid human parathyroid
hormone. Studies have shown that PTH acts on bone building cells
called osteoblasts to stimulate new bone growth and improve bone
density. Unlike agents already in use that prevent further bone
loss (such as estrogen and bisphosphonate), synthetic PTH may have
the potential to replace depleted bone stores.
