WASHINGTON — U.S. regulators Tuesday approved Eli Lilly and Co.'s new osteoporosis treatment and its new drug for attention deficit hyperactivity disorder.
Forteo, a once-a-day injection, is the first U.S.-approved treatment for osteoporosis to stimulate formation of new bone. The Food and Drug Administration cleared Forteo for treating men and post-menopausal women who have the bone-thinning disease and a high risk of fracture.
Later Tuesday, the FDA announced it had cleared Lilly's Strattera, which the agency said was the first new drug in three decades for treating the symptoms of attention deficit hyperactivity disorder.
Strattera is believed to be a less likely candidate for abuse by patients than other attention-deficit drugs, because it is the only FDA-approved treatment for the disorder that is not a stimulant.
It is approved for use by children, adolescents and adults for control of symptoms of ADHD, a condition that affects about 12 million Americans, including an estimated 8 million adults.
Its symptoms include poor attention and concentration and low impulse control. Some studies have suggested the disorder can be inherited. It is estimated that up to 60% of children with ADHD continue to have symptoms as adults.
Atomoxetine HC1 has not been approved for use by children younger than age 6. It also is not approved for use with monoamine oxidase inhibitor, an antidepressant, or in patients with narrow angle glaucoma.
Forteo is an advance for treating osteoporosis because it works differently from older drugs that stop or slow bone loss.
Forteo "has the capacity to turn on bone-forming cells ... and to actually make more bone. That's very appealing in patients with severe osteoporosis," Dr. Ethel Siris, director of the Toni Stabile Center for the Prevention and Treatment of Osteoporosis at Columbia-Presbyterian Medical Center, said in an interview. Siris also is a consultant for Lilly.
"I'm thrilled. We've been waiting for this," Siris said of Forteo's approval.
An estimated 8 million women and 2 million men in the United States have osteoporosis, a progressive thinning of the bones that can increase the risk of spine, wrist and hip fractures.
Forteo, which is known generically as teriparatide, is a fragment of a natural hormone called the human parathyroid hormone.
Lilly's research showed Forteo increased bone mineral density in postmenopausal women treated for an average of 19 months. Forteo reduced the relative risk of spinal fractures by 65% when compared with a placebo.
Forteo's label will carry a "black box" warning explaining that animal studies showed an increase in the number of rats developing osteosarcoma, a rare but serious bone cancer.
"In human studies, no osteosarcomas were reported, but the possibility that humans treated with [Forteo] may face an increased risk of developing this cancer cannot be ruled out," the FDA said in a statement.
Patients also will be told about the issue in a medication guide to be distributed by pharmacists each time Forteo is dispensed.