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:
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
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 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 www.rocheusa.com.
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 www.gsk.com.
For more information or full prescribing information, contact:
Roche:
Terence Hurley
(973) 562-2882
GSK:
Veronica Grosshandler
(919) 483-2839
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