Novartis therapy Lucentis® recommended for approval in EU to treat patients with vision loss due to Diabetic Macular Edema, a serious complication of diabetes
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Novartis International AG /
Novartis therapy Lucentis® recommended for approval in EU to treat patients with
vision loss due to Diabetic Macular Edema, a serious complication of diabetes
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* CHMP positive opinion supports Lucentis approval in EU for treatment in
patients with visual impairment due to diabetic macular edema (DME)
* Pivotal data shows Lucentis provided rapid, superior and sustained vision
gains compared to the current standard of care
* Diabetes-associated eye diseases such as DME are a leading cause of
blindness in most developed countries in the working-age population
Basel, October 22, 2010 - Novartis has received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP) for Lucentis(®)
(ranibizumab) for the treatment of patients with visual impairment due to
diabetic macular edema (DME), a leading cause of blindness in the working-age
population in most developed countries.
"Lucentis was designed specifically for use in the eye, and its efficacy and
safety have now been demonstrated in patients suffering loss of vision due to
diabetic macular edema through a robust program of clinical trials," said David
Epstein, Division Head of Novartis Pharmaceuticals.
The submission was supported by data from two Novartis-funded clinical trials,
RESTORE and RESOLVE, which showed that Lucentis was superior in providing rapid
and sustained visual acuity gain versus sham (dummy therapy) or laser therapy,
the current standard of care. The RESTORE study showed patients treated with
Lucentis alone or with Lucentis plus laser therapy achieved an average 5.9
letters and 5.5 letters gain in visual acuity at 12 months, respectively,
compared to laser-treated patients as measured on a standard ETDRS eye chart.
The RESOLVE study showed that Lucentis-treated patients achieved an average
11.7 letters gain in visual acuity at 12 months compared to sham-treated
patients, some of whom received laser treatment.
The pivotal data from RESTORE and RESOLVE are further supported by results of an
independent US study conducted by the Diabetic Retinopathy Clinical Research
Network (DRCR.net), showing that at one year nearly 50% of patients' eyes
treated with Lucentis and laser therapy improved their visual acuity by 10
letters or more, compared to 28% with laser alone. In addition, the study
demonstrated superior gains in visual acuity among Lucentis-treated patients up
to two years.
Lucentis was generally well tolerated in clinical studies, either when given as
monotherapy or when combined with laser treatment. Its safety profile was
consistent with that previously reported in large controlled clinical trials,
and in rigorous monitoring since Lucentis was first approved for wet age-related
macular degeneration (AMD). Lucentis is currently licensed in more than 85
countries for the treatment of wet AMD.
Diabetic macular edema (DME) is a consequence of diabetic retinopathy - the most
common diabetic eye complication, characterized by changes in the blood vessels
of the retina - to the light-sensitive layer at the back of the eye. In patients
with DME, leakage from these abnormal blood vessels occurs in the central
portion of the retina, called the macula. Because this part of the eye is
responsible for sharp central vision, DME can lead to significant visual
impairment. Visual impairment due to DME affects approximately 1-3% of patients
with diabetes, and DME is a leading cause of blindness in the working-age
population in most developed countries.
Lucentis offers an entirely new pharmacological approach to treatment compared
to the current standard of care for DME that involves the use of laser burns to
stop the capillary leakage and to reduce swelling. Lucentis is an antibody
fragment that is injected into the eye and acts by neutralizing vascular
endothelial growth factor (VEGF), a protein that is known to increase vascular
permeability, resulting in capillary leakage and macular edema in patients with
diabetes.
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 retinal vein occlusion (RVO). In addition,
Genentech is conducting two Phase III studies, RISE and RIDE, in patients with
diabetic macular edema. The results are expected in 2011. Novartis has exclusive
rights in the rest of the world and plans to file in the European Union for
approval of Lucentis for the treatment of visual impairment due to macular edema
following RVO.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommended," "plans," or similar expressions, or by
express or implied discussions regarding potential new indications or labeling
for Lucentis 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 submitted or approved for any additional
indications or labeling in any market. 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 clinical trial results, including unexpected new
clinical data and unexpected additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally;
competition in general; government, industry and general public pricing
pressures; 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 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
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Datum: 22.10.2010 - 13:35 Uhr
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