Novartis gains positive CHMP opinion for Lucentis® (ranibizumab) to treat vision loss due to macular edema secondary to RVO
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Novartis International AG /
Novartis gains positive CHMP opinion for Lucentis® (ranibizumab) to treat vision
loss due to macular edema secondary to RVO
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* Lucentis recommended for approval in EU for visual impairment due to macular
edema secondary to branch- and central-retinal vein occlusion (RVO)
* Pivotal data show rapid and significant improvements in visual acuity at six
months with Lucentis treatment compared to standard of care, with gains
sustained to 12 months
* RVO is a sudden-onset disease where patients suffer from visual impairment
and associated difficulties in daily activities such as reading and driving
Basel, March 18, 2011 - Novartis has received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP) for Lucentis(®)
(ranibizumab) to treat patients with visual impairment due to macular edema
secondary to retinal vein occlusion (RVO).
Lucentis has been shown to improve vision and vision related quality of life for
patients with visual impairment due to macular edema secondary to both branch-
RVO (BRVO) and central-RVO (CRVO).
"An effective therapy to treat the second most common cause of vision loss due
to retinal vascular disease represents a welcome benefit to patients," said
Frank G Holz, MD, Professor, Department of Ophthalmology, University of Bonn,
Germany. "In addition, it is important for physicians to have the option of a
well researched therapy like Lucentis."
The recommendation to approve Lucentis was based on data from two Phase III
studies in patients with BRVO (BRAVO) and CRVO (CRUISE). These studies showed
that approximately 60% of BRVO and 48% of CRVO patients treated with monthly
Lucentis gained at least 15 letters of visual acuity at six months, compared
with 29% and 17% of those treated according to current standard practice,
respectively. Patients maintained their visual acuity gains through to 12 months
with as-needed dosing of Lucentis.
"We are committed to being a leader in ophthalmology and providing effective
licensed therapies that make a difference in people's lives," said David
Epstein, Division Head of Novartis Pharmaceuticals. "If approved, Lucentis would
be the first anti-VEGF therapy licensed for the treatment of RVO in Europe. This
would be in addition to the Lucentis approvals for patients with wet age related
macular degeneration and patients with vision loss due to diabetic macular
edema."
The pivotal data also showed that patients with BRVO experienced a mean gain
from baseline of 18.3 letters in visual acuity at month six with monthly
Lucentis injections, compared with a gain of 7.3 letters with current standard
practice. Patients with CRVO experienced a mean gain from baseline of 14.9
letters at month six with monthly Lucentis injections, compared with a gain of
0.8 letters with current standard practice.
The safety data from the BRAVO and CRUISE trials were similar to previous
studies examining Lucentis, with no new adverse events reported. At six months
the most common ocular adverse events that occurred in the Lucentis-treated
patients included conjunctival hemorrhage (48%) and eye pain (17%). In the BRAVO
trial, there was one case of endophthalmitis, two arterial thrombo-embolic
events, fatal hemorrhagic stroke and non-fatal myocardial infarction. One case
of non-fatal myocardial infarction was reported in the sham group. In the CRUISE
trial, systemic safety events included one case of either myocardial infarction
or acute coronary syndrome in each of the three groups. There were no
cerebrovascular accidents or deaths.
RVO is usually the result of a blockage forming in a blood vessel in the retina,
which is the light-sensitive layer at the back of the eye. In CRVO, the blockage
occurs in the main retinal vein at the optic nerve. In BRVO, the blockage occurs
in one of the four branches of the main retinal vein. Both CRVO and BRVO can
lead to swelling of the macula, which is the central portion of the retina. This
swelling of the macula, or macular edema, is the most common cause of visual
impairment in patients with RVO. RVO often leads to increased production of
vascular endothelial growth factor (VEGF), which can exacerbate the RVO
complications.
Laser treatment, the current standard of care for patients with macular edema in
BRVO, may provide gradual and partial improvements in visual acuity, though many
patients fail to regain vision despite treatment. Laser therapy is not indicated
for patients with macular edema in CRVO. Currently, observation is the usual
course of action available to these patients.
Lucentis is an antibody fragment that is injected into the eye and acts by
neutralizing VEGF. Lucentis is currently licensed in more than 85 countries for
the treatment of wet age-related macular degeneration (AMD) and in the European
Union for visual impairment due to diabetic macular edema.
Lucentis was developed by Genentech and Novartis. Genentech has the commercial
rights to Lucentis in the United States, where Lucentis is also approved for the
treatment of macular edema following RVO. Novartis has exclusive rights in the
rest of the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommended," "can," "may," "committed," "would,"
"recommendation," "expected," or similar expressions, or by express or implied
discussions regarding potential new indications or labeling for Lucentis, or the
timing of any such new indications or labeling, or regarding potential future
revenues from Lucentis. You should not place undue reliance on these
statements. Such forward-looking statements reflect the current views of
management regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with Lucentis to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that Lucentis
will be approved for any additional indications or labeling in any market, or at
any particular time. Nor can there be any guarantee that Lucentis will achieve
any particular levels of revenue in the future. In particular, management's
expectations regarding Lucentis could be affected by, among other things,
unexpected regulatory actions or delays or government regulation generally;
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; competition in
general; government, industry and general public pricing pressures, and
unexpected reimbursement decisions; the company's ability to obtain or maintain
patent or other proprietary intellectual property protection; the impact that
the foregoing factors could have on the values attributed to the Novartis
Group's assets and liabilities as recorded in the Group's consolidated balance
sheet, and other risks and factors referred to in Novartis AG's current Form 20-
F on file with the US Securities and Exchange Commission. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated, believed,
estimated or expected. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2010, the Group's continuing operations achieved net sales of
USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding
impairment and amortization charges) was invested in R&D throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 119,000 full-time-equivalent associates (including 16,700 Alcon
associates) and operate in more than 140 countries around the world. For more
information, please visithttp://www.novartis.com.
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Datum: 18.03.2011 - 13:19 Uhr
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News-ID 52566
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