SOURCE: Roche and GSK

March 25, 2005 11:53 ET

FDA Approves Once-Monthly Boniva® for Osteoporosis

First-Ever Monthly Single Tablet for Any Disease

NUTLEY, NJ and RESEARCH TRIANGLE PARK, NC -- (MARKET WIRE) -- March 25, 2005 -- The U.S. Food and Drug Administration (FDA) today approved once-monthly oral Boniva® (ibandronate sodium) 150 mg Tablets, the first and only once-a-month medicine for the treatment of postmenopausal osteoporosis, Roche and GlaxoSmithKline (GSK) (NYSE: GSK) announced.

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.

"Boniva is the first and only once-monthly osteoporosis medication that maintains and actually builds bone density," said Ronald Emkey, M.D., clinical trial investigator and Medical Director of Radiant Research, Reading, PA. "The approval of this medication is significant because it offers patients a new treatment option that is effective and easy to take."

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.

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.

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, see contact information at the end of the news release or go to

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 unique once-monthly regimen. For more information on this program call 1-800-4BONIVA.

"The patients in my clinical trials found easy ways to remember their once-monthly Boniva, such as writing a note on their calendar or taking it the first Sunday of each month," Dr. Emkey said. "This support program will be another useful tool for patients."

About Osteoporosis

Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. 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 low bone mass (osteopenia),(2) placing them at increased risk for osteoporosis. Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. Together, osteoporosis and osteopenia are expected to affect an estimated 52 million women and men age 50 and older by 2010, and 61 million by 2020.(2) Direct medical costs of osteoporosis total nearly $18 billion in the U.S. each year.1

Roche and GSK Collaboration

In December 2001, F. Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries except Japan. The Roche and GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.

About Roche

Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. For further information, visit

About GSK

GSK, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GSK on the World Wide Web at


(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.

Contact Information