FDA approves Boniva 150mg for osteoporosis -- first-ever monthly single tablet for any disease

Breaking News -- March 25, 2005

FDA approves Boniva 150mg for osteoporosis -- first-ever monthly single tablet for any disease

NUTLEY, N.J. and RESEARCH TRIANGLE PARK, N.C., March 25, 2005 -- Roche and GlaxoSmithKline announced that the FDA has approved once-monthly oral Boniva (ibandronate sodium) 150 mg Tablets for the treatment of postmenopausal osteoporosis.

Boniva is the first-ever oral treatment administered as one tablet once a month for any chronic disease. With once-monthly Boniva, an effective bisphosphonate, patients would take 12 tablets a year versus 52 required with current weekly bisphosphonate treatments.

Why monthly Boniva?

This new treatment option comes in the wake of the Surgeon General's Report elevating osteoporosis to a major public health threat on par with smoking and obesity [1]. Forty-four million Americans over 50 years of age are affected by or at risk for osteoporosis, which causes bones to become weak and more likely to break, and can result in severe pain, deformity, disability, hospitalization and even death [2]. To improve persistence, the Surgeon General's Report has recommended, among various measures, simplifying and organizing treatment regimens [1].

"Osteoporosis is a serious, widespread and growing public health threat. We welcome any new treatment options such as Boniva that will help patients address this all too prevalent disease," said Judith Cranford, Executive Director, National Osteoporosis Foundation [2].

Developed in response to patient need, once-monthly Boniva was approved based on a supplemental new drug application. Once-monthly oral Boniva is not currently approved for use outside of the U.S., although it is undergoing regulatory review in markets across the world, including Europe, where it will be marketed under the trademark "Bonviva".

Boniva 150 mg once-monthly and Boniva 2.5 mg daily are indicated for the treatment and prevention of postmenopausal osteoporosis. Once-monthly Boniva is expected to be available by prescription in U.S. pharmacies in April.

Clinical trial results [3]

Daily Boniva (2.5 mg) was approved for the treatment and prevention of osteoporosis based on studies showing that, over three years, it significantly reduced the risk of new vertebral fractures in women with postmenopausal osteoporosis and increased bone mineral density (BMD) in postmenopausal women without osteoporosis. Once-monthly oral Boniva (150 mg) was approved based on results from the MOBILE study (Monthly Oral iBandronate In LadiEs), a randomized, double -blind, multinational, non-inferiority trial in 1,602 women with postmenopausal osteoporosis. MOBILE showed the following:

  • The monthly dose was at least equivalent to the daily dose in increasing BMD after one year at the
    lumbar spine and other skeletal sites.
  • The mean increase from baseline in lumbar spine BMD was 4.9 percent in the once-monthly group
    and 3.9 percent in the daily group (p=0.002).
  • The once-monthly group also had consistently higher BMD increases at the other skeletal sites
    compared to the daily group.

Important Safety Information

Boniva is contraindicated in patients unable to stand or sit upright for at least 60 minutes, with uncorrected hypocalcemia, or with known hypersensitivity to any component of Boniva. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. Boniva is not recommended in patients with severe renal impairment. Adequate intake of calcium and Vitamin D is important in all patients [3].

Rarely, patients have reported severe bone, joint and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Additionally, osteonecrosis of the jaw has rarely been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures. The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7.8 percent vs. Boniva 2.5 mg 5.3 percent), hypertension (6.3 percent vs. 7.3 percent), dyspepsia (5.6 percent vs. 7.1 percent), arthralgia (5.6 percent vs. 3.5 percent), nausea (5.1 percent vs. 4.8 percent) and diarrhea (5.1 percent vs. 4.1 percent). For complete prescribing information for Boniva, go to www.4boniva.com.

About once-monthly oral Boniva [3]

Once-monthly Boniva is a small, film-coated, easy-to-swallow tablet dosed at 150 mg. Patients should take Boniva with plain water on an empty stomach upon rising in the morning. They should remain upright and avoid food, drink and other medications for at least 60 minutes.

Patients who take Boniva are eligible to sign up for MyBONIVA, a patient support program designed to help enhance compliance (taking therapy as directed) and persistence (staying on therapy) with this once-monthly regimen. For more information on this program, call 1-800-4BONIVA.

References:

[1] Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and
Human Services, Office of the Surgeon General; 2004.

[2] America's Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation: The National Osteoporosis Foundation; February 2002.

[3] Boniva (ibandronate sodium) Tablets [prescribing information] Roche Laboratories Inc., Nutley, NJ; 2005.

Source: Roche and GlaxoSmithKline

Posted: March 2005


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