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New Osteoporosis Drug Dosed by IV Every 2/3 Mos
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"Osteoporosis Study Shows Boniva(TM) (Ibandronate Sodium) Increases Bone Density When Dosed Intravenously at Either Two- or Three-Month Intervals"
The Associated Press, Oct 19, 2004
Investigational I.V. Dosing Formulation May Provide Alternative to More Frequently Administered Bisphosphonates
The bisphosphonate Boniva (ibandronate sodium), taken in an investigational intravenous (I.V.) dosing regimen once every two or once every three months, was at least equivalent to the previously approved once-daily oral formulation in increasing spine bone mineral density (BMD) and reducing bone breakdown, and was generally well-tolerated. The findings(1), in women with postmenopausal osteoporosis, were reported at the annual meeting of the American College of Rheumatology.
``These findings are important because they show that Boniva has potential for an I.V. dosing regimen that may be convenient for many patients,'' said lead investigator Robert Recker, M.D., Chief of Endocrinology and Director of the Osteoporosis Research Center at the Creighton University School of Medicine in Omaha, Neb. ``I.V. administration provides a treatment option for osteoporosis not previously available with bisphosphonates.''
The U.S. Food and Drug Administration (FDA) approved a once-daily oral formulation of Boniva in May 2003. Roche and GlaxoSmithKline, which are co-developing the drug, are not marketing the daily dose but have been exploring less frequent dosing regimens before launching the product. The companies plan to submit a new drug application (NDA) to the FDA for an investigational I.V. formulation of Boniva in the near future. A supplemental new drug application (sNDA) for an investigational once-monthly oral dosing formulation of Boniva was submitted to the FDA in May 2004 for the treatment and prevention of postmenopausal osteoporosis.
Study and Findings
The new findings were one-year results from DIVA (Dosing Intra Venous Administration), a two-year multinational trial in 1,395 women with postmenopausal osteoporosis (lumbar spine BMD T-score 2.5) that compared the efficacy and safety of the FDA-approved oral daily ibandronate regimen with two intravenous regimens: 2 mg every two months or 3 mg every three months. At year one, lumbar spine BMD, the study's primary endpoint, increased more in the 2 mg and 3 mg I.V. dosing groups than in the daily oral dosing group (5.1 percent and 4.8 percent vs. 3.8 percent, respectively, p < 0.001). Substantial and comparable increases in hip BMD were also observed, and were greater in the I.V. groups than in the oral daily regimen. Clinically relevant decreases in bone breakdown (resorption, as measured by serum CTX) were observed in all three treatment groups. Both I.V. regimens were generally well-tolerated. Most common side effects observed in the trial were arthralgia (joint pain), influenza-like illness and headache.
About Boniva
Boniva (2.5 mg once-daily) is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Boniva increases bone mineral density and reduces the incidence of vertebral fractures. Boniva also may be considered for postmenopausal women who are at risk for developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and reduce the risk of vertebral fracture.
Boniva is contraindicated in patients unable to stand or sit upright for at least 60 minutes, patients with hypersensitivity to any component of this product, and patients with uncorrected hypocalcemia. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer.
Complete prescribing information is available through Roche and GSK. Boniva 2.5 mg once-daily is approved, but is not marketed.
About Osteoporosis
Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. Common and chronic conditions, osteoporosis and low bone mass (osteopenia) pose a major public health threat to more than 44 million Americans over age 50(2). In the U.S. today, ten million individuals, eight million of whom are women, are estimated to already have osteoporosis, and almost 34 million more are estimated to have osteopenia, placing them at increased risk for osteoporosis(2). Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. An estimated 52 million women and men age fifty plus are expected to be affected by osteoporosis and osteopenia by 2010 and 61 million are expected to be affected by 2020(2).
About the Roche/GSK Collaboration
In December 2001, Roche and GSK announced that they would co-develop and co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries, except Japan. The Roche/GSK collaboration provides expertise and commitment to bring new osteoporosis therapies to market as quickly as possible.
References
(1) Recker RR, Reid DM, Sambrook P, Hughes C, Ward P, Bonvoisin B, Adami S. Intermittent intravenous ibandronate injection regimens provide at least equivalent efficacy to daily oral ibandronate: 1-year results from DIVA. Poster presentation at the annual meeting of the American College of Rheumatology, October 16-21, 2004, San Antonio, Texas.
(2) America's Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation. The National Osteoporosis Foundation. February 2002.
For further information contact: Roche: Terence Hurley (973) 562-2882 GSK: Veronica Grosshandler (919) 483-2839
Copyright (c) 2004 Market Wire
Distributed by the Associated Press
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