Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced that the U.S. Food and Drug Administration
(FDA) has accepted to file the company's supplemental Biologics
License Application (sBLA) and granted Priority Review of Lucentis®
(ranibizumab injection) for the treatment of diabetic retinopathy,
an eye disease that impacts nearly 7.7 million Americans. The FDA
confirmed action date is February 6, 2015.
The sBLA was submitted August 7, 2014 to address the unmet need
for approved ocular medications for the treatment of diabetic
retinopathy. If approved by the FDA, Lucentis could be the first
eye medicine available for diabetic retinopathy patients.
“Diabetes has emerged as a global epidemic, with 29 million
people in the U.S. with diabetes at risk of diabetic eye disease,”
said Sandra Horning, M.D., chief medical officer and head of
Global Product Development. “We are committed to the treatment of
serious eye diseases for patients with diabetes and pleased the FDA
is moving forward in its consideration of Lucentis for diabetic
retinopathy.”
Diabetic retinopathy is the most common diabetic eye disease and
the leading cause of new cases of blindness in working-age
Americans.1 It is caused by changes in the blood vessels of the
retina, the light-sensitive tissue at the back of the eye necessary
for good vision. In its early stages, diabetic retinopathy is often
without symptoms.
Nearly 29 million Americans are living with diabetes. The longer
a person has diabetes, especially if it is poorly controlled, the
higher the risk for developing diabetic retinopathy. Diabetic
retinopathy eventually affects nearly all diabetes patients and can
lead to blindness if left untreated.2
Priority Review designation is granted by the FDA to medicines
that, if approved, would have the potential to provide significant
improvements in the safety or effectiveness of the treatment,
diagnosis, or prevention of serious conditions when compared to
standard applications.
The submission is based on results of the RISE and RIDE Phase
III trials in which meaningful improvements in the disease were
observed in a clinically significant proportion of diabetic
retinopathy patients treated with Lucentis at two years compared to
patients treated with sham injections (control group). Benefits of
Lucentis treatment were maintained during year three of treatment.
The safety in the RISE and RIDE Phase III trials was consistent
with previous studies.
Lucentis was the first FDA-approved medicine for diabetic
macular edema (DME), a major cause of vision loss in people with
diabetic retinopathy. It was approved August 10, 2012 based on the
RISE and RIDE trials.
About RISE and RIDE
RISE and RIDE are two identically-designed, parallel,
double-masked, sham treatment-controlled trials in 759 patients
with diabetic retinopathy and DME at baseline who were randomized
into three groups to receive monthly treatment with 0.3 mg
Lucentis, 0.5 mg Lucentis or sham injection. The primary objective
of the RISE and RIDE trials was to evaluate the safety,
tolerability and efficacy of Lucentis in DME patients as measured
by the primary efficacy endpoint of percentage of subjects gaining
≥ 15 letters in best corrected visual acuity (BCVA) score compared
with baseline at 24 months.
The efficacy of Lucentis for the treatment of diabetic
retinopathy was also assessed over three years in RISE and RIDE
patients with baseline diabetic retinopathy severity scores ranging
from 10 to 75 in the study eye (on the ETDRS diabetic retinopathy
severity scale). At Month 24, an exploratory analysis demonstrated
a higher proportion of patients treated with Lucentis had observed
a three-step or more improvement of their disease compared to sham,
as determined by color fundus photography. In the third year of the
studies, patients from the control group had the option to cross
over to receive monthly treatment with 0.5 mg Lucentis; patients
originally randomized to 0.3 mg or 0.5 mg Lucentis continued to
receive their assigned dose and patients were followed for 12
additional months. The benefits of Lucentis treatment achieved
at Month 24 were maintained through Month 36.
About Lucentis
Lucentis is a vascular endothelial growth factor (VEGF)
inhibitor designed to bind to and inhibit VEGF-A, a protein that is
believed to play a critical role in the formation of new blood
vessels (angiogenesis) and the hyperpermeability (leakiness) of the
vessels. Lucentis is FDA-approved for the treatment of wet
age-related macular degeneration (wet AMD), macular edema following
retinal vein occlusion (RVO), and diabetic macular edema (DME).
Genentech has conducted eight key clinical trials with Lucentis.
The medicine has been studied in 21 clinical trials worldwide in
more than 9,000 patients.
Lucentis was developed by Genentech. The company retains
commercial rights in the U.S. and Novartis has exclusive commercial
rights for the rest of the world.
Outside the U.S., Lucentis is approved in more than 100
countries to treat patients with wet AMD, for the treatment of DME,
and due to macular edema secondary to both branch retinal vein
occlusion (BRVO) and central retinal vein occlusion (CRVO).
Lucentis Important Safety Information
Lucentis is a prescription medication given by injection into
the eye, and it has side effects. Some Lucentis patients
have had detached retinas and serious infections inside the eye.
Patients should not use Lucentis if they have an
infection in or around the eye or are allergic
to Lucentis or any of its ingredients.
Uncommonly, Lucentis patients have had serious,
sometimes fatal, problems related to blood clots, such as heart
attacks or strokes.
Some patients have had increased eye pressure before and within
one hour of an injection.
Serious side effects include inflammation inside the eye and,
rarely, problems related to the injection procedure, such as
cataracts. These side effects can make vision worse.
The most common eye-related side effects are increased redness
in the white of the eye, eye pain, small specks in vision, and
increased eye pressure. The most common non-eye-related side
effects are nose and throat infections, headache, lung/airway
infections, and nausea.
If the eye becomes red, sensitive to light, or painful, or if
there is a change in vision, patients should call or visit an eye
doctor right away.
Lucentis is for prescription use only.
For additional safety information, please see Lucentis full
prescribing information, available here:
http://www.gene.com/download/pdf/lucentis_prescribing.pdf
About Genentech in Ophthalmology
Genentech's vision for ophthalmology is to bring innovative
therapeutics to patients with eye disease. Currently, the
company is investigating proprietary platforms for sustained drug
delivery through an ocular implant and has also initiated clinical
trials for patients with a specific biomarker who have geographic
atrophy (GA), an advanced form of dry AMD. Additional focus
includes working with bispecific molecules to
simultaneously address multiple eye disease targets, and
leveraging previous research in related therapeutic areas to
develop new treatments for vision-threatening conditions.
About Genentech
Founded more than 35 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious or
life-threatening medical conditions. The company, a member of the
Roche Group, has headquarters in South San Francisco, California.
For additional information about the company, please visit
http://www.gene.com.
References:
1 Prevent Blindness America Prevalence of Adult Vision
Impairment and Age-Related Eye Disease in America. Available at:
http://www.visionproblemsus.org/diabetic-retinopathy/diabetic-retinopathy-definition.html
2 [CDC] Centers for Disease Control and Prevention. National
diabetes Statistics Report, 2014. U.S. Department of Health and
Human Services, Centers for Disease Sham and Prevention [resource
on the internet; updated 2014; cited 2014 June 11]. Available at:
http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
GenentechMedia Contact:Allison Neves, 650-467-6800Investor
Contacts:Nina Goworek, 650-467-8737Karl Mahler, 011 41 61 687
8503
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