For easy comparison, here is the Lilly PR concerning the approval of Forteo:
>>Dec. 1, 02 - Eli Lilly and Company (NYSE: LLY) announced last week that the U.S. Food and Drug Administration (FDA) approved FORTEO® (teriparatide [rDNA origin] injection) for the treatment of osteoporosis in postmenopausal women who are at high risk for a fracture.
FORTEO was also approved to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for a fracture. These include men (or women) with a history of osteoporosis-related fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment.
FORTEO is the first in a new class of drugs called bone formation agents that work primarily to stimulate new bone by increasing the number and action of bone-forming cells called osteoblasts.
"With today's announcement of the approval of FORTEO, we have begun our journey of launching several new medicines by the middle of the decade," said Sidney Taurel, Lilly chairman, president and chief executive officer. "Lilly's innovation-driven strategy has yielded a pipeline of new medicines that, if approved, will advance patient care and lay the foundation for sustained, long-term growth for our company."
"This approval is very exciting because it is a new way to treat bones weakened by osteoporosis," said Ethel Siris, M.D., professor of clinical medicine at the College of Physicians and Surgeons of Columbia University. "It is our hope that the introduction of this therapy will usher in a new approach to treating more advanced forms of osteoporosis and fill an unmet need for these patients."
Until today, the only approved osteoporosis treatments were antiresorptives, which work mainly to slow or stop bone loss by reducing the number and action of bone-removing cells called osteoclasts. FORTEO actually stimulates the formation of new bone by increasing the number and action of bone-forming cells, called osteoblasts.
Clinical Trials
The FDA's approval of FORTEO was based on 24 clinical trials enrolling more than 2,800 postmenopausal women and men with osteoporosis. Pivotal Phase III clinical trial data - published in The New England Journal of Medicine (May 10, 2001) - 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 revealed that FORTEO reduced the relative risk of spinal fractures by 65 percent (9.3 percent 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 percent (2.9 percent 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 percent of women had an increase from baseline, with 72 percent achieving at least a 5 percent increase in spine BMD and 44 percent gaining 10 percent or more compared with placebo.
In a separate study in men with idiopathic or hypogonadal osteoporosis, FORTEO significantly increased BMD over 10 months of average treatment compared with placebo. The data showed that 94 percent of men had an increase in their spine BMD; 53 percent of men taking FORTEO had an increase of spine BMD greater than or equal to 5 percent at the closeout of the study compared with 10 percent of men in the placebo group. All patients in all arms of the studies received daily calcium and vitamin D supplements.
"The approval of FORTEO marks another important milestone in Lilly's commitment to remain at the forefront of osteoporosis research and treatment by providing new solutions for those patients who suffer from osteoporosis," said John C. Lechleiter, Ph.D., Lilly executive vice president, pharmaceutical products and corporate development.
FORTEO will be supplied in a disposable pen device that can be used for up to 28 days to give once-daily self-administered injections. FORTEO will be available in a 20 microgram (mcg) dose and should be taken for a period of up to 24 months. Lilly has also implemented a risk management program that includes comprehensive educational measures regarding the appropriate use of FORTEO in the target patient population. A Medication Guide explaining the details of the drug to the patient will accompany the product. FORTEO will have a black box warning in its package insert about the osteosarcoma findings in rats during preclinical testing.
Important Safety Information
In two-year studies in rats, teriparatide caused an increase in the incidence of osteosarcoma, a malignant bone tumor, that was dependent on dose and duration of treatment. Although no case of osteosarcoma has been reported in the patients who received FORTEO in clinical trials, it is not known if humans treated with FORTEO are at increased risk for this cancer.
FORTEO 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 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 FORTEO. Patients with high levels of calcium in their blood should not receive FORTEO 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-mcg dose approved for marketing were mild, similar to placebo and generally did not require discontinuation of therapy. Reported adverse events that appeared to be increased by FORTEO treatment were leg cramps and dizziness (2.6 and 8 percent, respectively), compared with placebo (1.3 percent and 5.4 percent, respectively).<<
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Cheers, Tuck |
