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FDA approves once-monthly treatment for osteoporosis
Monthly dose of Boniva (ibandronate sodium) may be more effective at increasing BMD than the once-daily formulation.
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The FDA has granted marketing approval to a once-monthly oral formulation of Boniva for treating osteoporosis in postmenopausal women, Roche and GlaxoSmithKline announced.
This is first oral medication to receive an approval for once-monthly administration as a treatment for any chronic disease, the companies noted.
The FDA based its approval decision on results from the MOBILE study (Monthly Oral iBandronate In LadiEs), a randomized, double-blind, multinational, non-inferiority trial involving 1602 women with postmenopausal osteoporosis. The study compared the efficacy of the monthly formulation to the daily formulation of Boniva (ibandronate sodium 2.5 mg). Clinical studies have shown that over three years significantly Boniva reduces the risk of new vertebral fractures in postmenopausal women with osteoporosis and increases bone mineral density (BMD) in postmenopausal women without osteoporosis, according to a joint press release by the two companies.
The MOBILE study found that the monthly dose of Boniva (ibandronate sodium 150 mg tablets) was at least equally effective as the existing daily dose in increasing BMD at the lumbar spine and at other skeletal sites. Patients receiving the once-monthly dose experienced a mean 4.9% increase in lumbar spine BMD compared to a mean increase of 3.9% among daily-dose patients (P = .002), according to the release.
Patients receiving the once-monthly dose also had consistently higher BMD increases at other skeletal sites compared to patients in the daily dose group, the companies said.
Adverse events reported in the study included the following:
- abdominal pain in 7.8% of monthly- vs. 5.3% of daily-dose patients;
- hypertension in 6.3% of monthly- vs. 7.3% of daily-dose patients;
- dyspepsia in 5.6% of monthly- vs. 7.1% of daily-dose patients;
- arthralgia in 5.6% of monthly- vs. 3.5% of daily-dose patients;
- nausea in 5.1% of monthly- vs. 4.8% of daily-dose patients; and
- diarrhea in 5.1% of monthly- vs. 4.1% of daily-dose patients.
Although not currently approved for use outside of the United States, Roche and GlaxoSmithKline have entered into an agreement to co-promote Boniva for its osteoporosis indication in all countries except Japan. The drug is currently undergoing regulatory review in several markets worldwide, including Europe.
The companies expect the once-monthly formulation to be available by prescription in the United States in April.