The U.S. Food and
Drug Administration (FDA) has approved Boniva® (ibandronate sodium)
Injection, the first intravenous (IV) medication for the treatment of
postmenopausal osteoporosis, Roche and GlaxoSmithKline (GSK) announced
today. Boniva Injection, the first quarterly medication for the treatment
of postmenopausal osteoporosis, is a member of the bisphosphonate class,
which is the most frequently prescribed medicine for osteoporosis.(1) It is
administered by a healthcare professional once every three months.
"Boniva Injection is a truly novel osteoporosis therapy. It represents an
important new opportunity to bring the bone-strengthening benefits of
Boniva to more women -- including those who have difficulty with dosing
requirements of oral bisphosphonates," said Robert R. Recker, M.D.,
M.A.C.P., F.A.C.E., Director, Creighton University Osteoporosis Research
Center, Omaha, Neb., an investigator in Boniva clinical trials and a
leading expert in osteoporosis.
Boniva Injection, administered as a 15-30 second IV injection, will provide
an alternative for patients who have difficulty with oral bisphosphonate
dosing requirements, including an inability to sit upright for 30 to 60
minutes and/or swallow a pill. Additionally, because Boniva Injection will
be administered by healthcare professionals, clinicians will have a greater
awareness of patient compliance with therapy. Boniva Injection was approved
by the FDA based on results of the DIVA study (Dosing IntraVenous
Administration), a clinical trial in 1,358 women with postmenopausal
osteoporosis. Boniva Injection will be available early this year.
The FDA approved once-monthly Boniva in March 2005 as the first
once-a-month tablet for postmenopausal osteoporosis. The once-monthly
tablet (150 mg) became available in April 2005.
Approval of Boniva Injection and once-monthly oral Boniva follow a Surgeon
General's Report that elevated 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, a disease that
causes bones to become weak and more likely to break,(1) and can result in
severe pain, deformity, disability, hospitalization and even death.(1)
"Osteoporosis is a serious, widespread and growing public health threat. We
welcome any new treatment options such as Boniva Injection that will help
patients address this all too prevalent disease," said Judith Cranford,
Executive Director, National Osteoporosis Foundation.
Clinical Trial Results
Boniva was first approved in a daily oral tablet formulation (2.5 mg) for
the treatment and prevention of postmenopausal osteoporosis based on
studies showing 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. Boniva
Injection (3 mg once every three months) was approved based on results from
the DIVA study, a randomized, double-blind, multinational, non-inferiority
trial in 1,358 women with postmenopausal osteoporosis who were treated with
either an IV injection or the once-daily oral formulation of Boniva.(2) All
patients received supplemental calcium and vitamin D throughout the trial.
DIVA showed that the average increase in lumbar spine BMD at one year in
patients treated with Boniva Injection (3 mg once every three months) was
statistically superior to that in patients treated with the daily oral
tablets (4.5 percent vs. 3.5 percent for the two treatments, respectively,
p < 0.001). The study also showed that patients treated with Boniva
Injection had consistently higher BMD increases in the total hip and other
skeletal sites (femoral neck and trochanter) than patients treated with
oral daily Boniva.(5)
Important Safety Information
Boniva Injection(5)
Boniva Injection is indicated for the treatment of osteoporosis in
postmenopausal women. Boniva is contraindicated in patients with
uncorrected hypocalcemia or known hypersensitivity to Boniva or any of its
excipients. Boniva Injection, like other bisphosphonates administered
intravenously, may cause a transient decrease in serum calcium values.
Hypocalcemia, hypovitaminosis D and other disturbances of bone and mineral
metabolism must be effectively treated before starting therapy. Patients
must receive supplemental calcium and vitamin D. Boniva must only be
administered intravenously by a healthcare professional. Patients who
receive Boniva Injection should have serum creatinine measured prior to
each dose. Boniva Injection should not be administered to patients with
severe renal impairment (creatinine clearance < 30 mL/min). Osteonecrosis of
the jaw has rarely been reported in patients treated with bisphosphonates;
most cases have been in cancer patients undergoing dental procedures who
received intravenous bisphosphonates.
In a one-year study comparing Boniva Injection and Boniva Tablets 2.5 mg
daily, the overall safety and tolerability profiles with the two dosing
regimens were similar. The most commonly reported adverse events (5 percent
or higher) regardless of causality were arthralgia (9.6 percent Boniva
Injection vs 8.6 percent Boniva Tablet 2.5 mg), back pain (7.0 percent vs.
7.5 percent), influenza (4.7 percent vs. 8.0 percent), hypertension (5.3
percent vs. 7.1 percent), abdominal pain (5.1 percent vs. 5.6 percent), and
nasopharyngitis (3.4 percent vs. 6.0 percent). In some patients, acute
phase reaction-like events have been reported, usually only after the first
injection. In most cases, no specific treatment was required and symptoms
subsided in 24-48 hours.
Boniva Tablets(2)
Boniva Tablets is contraindicated in patients unable to stand or sit
upright for at least 60 minutes, with uncorrected hypocalcemia, or with
known hypersensitivity to Boniva or any of its excipients. 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.
About Boniva
Boniva Injection 3 mg/3 mL will be available in boxes containing one
single-use, clear glass prefilled syringe, along with one needle and an
alcohol swab.
Once-monthly oral Boniva is a small, film-coated, easy-to-swallow tablet
dosed at 150 mg. Boniva is also available in an oral 2.5 mg tablet taken
once daily.
About Osteoporosis
Osteoporosis (literally "porous bones") is a disease in which bones become
brittle and more likely to break. In the U.S., approximately 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),(3) 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.(3) Direct medical costs of osteoporosis total nearly $18 billion in
the U.S. each year.(2)
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:
Maureen Byrne
(973) 562-2203
GSK:
Veronica Grosshandler
(919) 483-2839