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Basel,
9 January 2006
New injection brings benefits of Boniva to more
women
Roche and GlaxoSmithKline (GSK) announce that the
U.S. Food and Drug Administration (FDA) has approved
a new, quarterly intravenous (I.V.) injection of
the potent and highly effective osteoporosis drug
Boniva (ibandronic acid). This is the first ever
I.V. injection for the treatment of postmenopausal
osteoporosis to be approved by the FDA.
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Stages
of osteoporosis
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Boniva
(known as Bonviva outside the U.S.), is already approved
as an effective and well-tolerated1
once-monthly tablet in 33 countries. However, for
some women with postmenopausal osteoporosis, oral
bisphosphonates are not suitable. These women may
be unable to take oral bisphosphonate therapy due
to another medical condition or because they can not
stay upright for the required length of time.* For
these women, Boniva Injection offers a way to gain
the proven bone strengthening benefits of bisphosphonate
therapy.
William M. Burns, CEO Division Roche Pharma commented:
“The U.S. approval of quarterly Boniva Injection represents
an important new opportunity to bring the bone-strengthening
benefits of bisphosphonate therapy to more women.
Boniva will now be available as two innovative treatment
options that may help patients to stay on therapy.”
Gorana Dasic, the US Ibandronate Medical Director
at GSK said: “Boniva Injection is the first IV bisphosphonate
to be approved for osteoporosis treatment anywhere
in the world. It was developed in response to the
needs of a specific group of patients and supports
our vision to bring bisphosphonate treatment options
to more postmenopausal women.”
Boniva Injection is presented as a pre-filled syringe
and is administered once every three months by a healthcare
professional as a 15 - 30 second injection.
The FDA approval of Boniva Injection was based on
one year results from the two year DIVA (Dosing IntraVenous
Administration) study.2 DIVA investigated the efficacy,
safety and tolerability of Boniva Injection in comparison
to the once-daily oral formulation of Boniva and found
it to be highly effective and well-tolerated.2,3
Previous studies have shown that once-daily oral ibandronate
reduced the risk of vertebral fracture in women with
postmenopausal osteoporosis by 62% when taken over
three years.4
The Marketing Authorisation Application (MAA) for
Bonviva Injection was submitted to the European Medicines
Agency (EMEA) in April 2005.
About DIVA
DIVA (Dosing IntraVenous Administration) is a multinational,
randomised, double-blind, active control multicentre
study in more than 1,300 women with postmenopausal
osteoporosis aged between 55 and 80 years of age.
DIVA compares the efficacy, safety, and tolerability
of the approved once-daily oral ibandronate 2.5mg
regimen with two novel I.V. regimes: 2mg every two
months and 3mg every three months, with lumbar spine
bone mineral density at one year as the primary endpoint.
• One Year Results2
The FDA approval of Boniva Injection was based on
one year results from the DIVA study.2
The results 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.2
• Two Year Results3
The two-year findings from the DIVA study were presented
at the 2005 Annual Scientific Meeting of the American
College of Rheumatology, November 12-17 2005.3 For patients who received the
3mg ibandronate every 3 months dosing regimen:
• BMD at the lumbar spine increased more in the I.V.
dosing group than in the daily oral dosing group (6.3
percent vs. 4.8 percent).
• Substantial increases in bone density at the hip
(a significant non-vertebral site) were also observed,
and were also greater in the I.V. group than in the
oral daily regimen (3.1 percent vs. 2.2 percent).
• Clinically relevant decreases in bone breakdown
(measured by the biochemical marker of bone resorption,
serum CTX) were observed in all treatment groups.
The I.V. regimen was well tolerated.2
The most common side effects for I.V. ibandronate
reported in a one-year study comparing Boniva Injection
and Boniva Tablets 2.5 mg daily were arthralgia, back
pain, influenza / influenza-like symptoms, hypertension,
abdominal pain and nasopharyngitis.2 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 Injection should not be administered
to patients with severe renal impairment.2
Roche/GSK Collaboration
In December 2001, F Hoffmann-La Roche (Roche) and
GlaxoSmithKline (GSK) announced their plans to co-develop
and co-promote Boniva for the treatment and prevention
of postmenopausal osteoporosis in a number of major
markets, excluding Japan. The Roche/GSK collaboration
provides expertise and commitment to bringing new
osteoporosis therapies to market as quickly as possible.
About Roche
Headquartered in Basel, Switzerland, Roche is one
of the world’s leading research-focused healthcare
groups in the fields of pharmaceuticals and diagnostics.
As a supplier of innovative products and services
for the early detection, prevention, diagnosis and
treatment of disease, the Group contributes on a broad
range of fronts to improving people’s health and quality
of life. Roche is a world leader in diagnostics, the
leading supplier of medicines for cancer and transplantation
and a market leader in virology. Roche employs roughly
65,000 people in 150 countries and has R&D agreements
and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group
is available on the Internet (http://www.roche.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.
*Oral bisphosphonates are taken
according to a very strict treatment regime which
involves remaining upright and not eating, drinking
(except water) or taking other medications for a period
of time before and after the therapy has been taken.
All trademarks used
or mentioned in this release are legally protected.
Further information:
- Roche Healthkiosk, Osteoporosis
- About
GSK
References
1. Cooper C, Delmas PD, Felsenberg D, Hughes C, Mairon
N et al. Two-year efficacy and tolerability of once
monthly oral ibandronate in postmenopausal osteoporosis:
the MOBILE study. Abstract presented at the Annual
European Congress of Rheumotology, Vienna, Austria
8-11 June 2005.
2. BONIVA (ibandronate sodium) INJECTION [prescribing
information] Roche Laboratories Inc., Nutley, NJ;
2006.
3. Emkey R, Zaidi M, Lewiecki EM, Burdesk A, Mairon
N et al. Two-year efficacy and tolerability of intermittent
intravenous ibandronate injections in postmenopausal
osteoporosis: the DIVA study. Abstract presented at
the Annual Meeting of the American College of Rheumatology,
12-17 November 2005, San Diego, USA.
4. Chesnut C, Skag A, Christiansen C, Recker R, Stakkestad
J et al. Effects of Oral Ibandronate Administered
Daily or Intermittently on Fracture Risk in Postmenopausal
Osteoporosis. Journal of Bone & Mineral Research
2004; 10 (8): 1421-1429 |
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