FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three
leading causes of vision loss
- Vabysmo PFS is the first
and only syringe prefilled with an FDA-approved bispecific antibody
to treat retinal conditions that can cause blindness
- Designed to simplify
administration, Vabysmo PFS provides retina specialists a
ready-to-use option
- Vabysmo PFS will be
available for people living with nAMD, DME and
RVO
Basel, 05 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today the United States Food and Drug Administration (US
FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose
prefilled syringe (PFS) for use in the treatment of neovascular or
‘wet’ age-related macular degeneration (nAMD), diabetic macular
edema (DME) and macular edema following retinal vein occlusion
(RVO). Together, these three conditions affect close to 80 million
people globally.1-4 The Vabysmo PFS will become
available to United States (US) retina specialists and their
patients in the coming months.
“We are pleased that the US FDA has approved the Vabysmo PFS for
people living with neovascular age-related macular degeneration,
diabetic macular edema and retinal vein occlusion, which are some
of the leading causes of vision loss,” said Levi Garraway, M.D.,
Ph.D., Roche’s Chief Medical Officer and Head of Global Product
Development. “While many retina specialists are already using
Vabysmo as a first-line treatment, this new offering should make it
even simpler to administer, thereby enhancing the treatment
experience for both physicians and patients.”
Vabysmo PFS delivers the same medicine as the currently
available Vabysmo vials in an alternative, ready-to-use format.
Vabysmo will continue to be available in a 6.0 mg
vial.5
Vabysmo is the first and only bispecific antibody approved for
the eye and has demonstrated rapid and robust vision improvements
and retinal drying in nAMD, DME and RVO.5-13 Retinal
drying is an important clinical measure, as swelling from excess
fluid in the back of the eye is associated with distorted and
blurred vision.14
To date, Vabysmo is approved in more than 95 countries for nAMD
and DME, and in several countries, including the US and Japan, for
RVO.5,7,15-18 Review by other
health authorities across the globe is ongoing. More than four
million doses of Vabysmo have been distributed globally since its
initial US approval in 2022.18
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the
eye.5-7 It targets and inhibits two signalling pathways
linked to a number of vision-threatening retinal conditions by
neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth
factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by
destabilising blood vessels, causing new leaky blood vessels to
form and increasing inflammation. By blocking pathways involving
Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood
vessels.6,19 Vabysmo is approved in more than 95
countries around the world, including the United States (US),
Japan, the United Kingdom and the European Union for people living
with neovascular or ‘wet’ age-related macular degeneration and
diabetic macular edema and in several countries, including the US
and Japan, for retinal vein occlusion.5,7,15-19 Review
by other regulatory authorities is ongoing.
About Roche in ophthalmology
Roche is focused on saving people’s eyesight from the leading
causes of vision loss through pioneering therapies. Through our
innovation in the scientific discovery of new potential drug
targets, personalised healthcare, molecular engineering, biomarkers
and continuous drug delivery, we strive to design the right
therapies for the right patients.
We have the broadest retina pipeline in ophthalmology, which is
led by science and informed by insights from people with eye
diseases. Our pipeline includes gene therapies and treatments
across multiple vision-threatening conditions, including diabetic
eye diseases, geographic atrophy and autoimmune conditions, such as
thyroid eye disease and uveitic macular edema.
Applying our extensive experience, we have already brought
breakthrough ophthalmic treatments to people living with vision
loss. Susvimo® (previously called Port Delivery System with
ranibizumab) 100 mg/mL for intravitreal use via ocular implant was
approved by the United States Food and Drug Administration in
2021.20 Vabysmo® (faricimab) is the first bispecific
antibody approved for the eye, which targets and inhibits two
signalling pathways linked to a number of vision-threatening
retinal conditions by neutralising angiopoietin-2 and vascular
endothelial growth factor-A.5-7,19 Lucentis®
(ranibizumab injection)* was the first treatment approved to
improve vision in people with certain retinal
conditions.21
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
*Lucentis® (ranibizumab injection) was developed by Genentech, a
member of the Roche Group. Genentech retains commercial rights in
the United States and Novartis has exclusive commercial rights for
the rest of the world.
All trademarks used or mentioned in this release are protected
by law.
References
[1] Bright Focus Foundation. Age-related macular degeneration:
facts & figures. [Internet; cited July 2024]. Available from:
https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
[2] Im JHB, et al. Prevalence of diabetic macular edema (DME) based
on optical coherence tomography in people with diabetes: a
systematic review and meta-analysis. Surv Ophthalmol. 2022
Jul-Aug;67(4):1244-1251.
[3] The Lancet. Diabetes: a defining disease of the 21st century.
Lancet. 2023 Jun 24;401(10394):2087.
[4] Song P, et al. Global epidemiology of retinal vein occlusion
(RVO): a systematic review and meta-analysis of prevalence,
incidence, and risk factors. J Glob Health. 2019
Jun;9(1):010427.
[5] United States Food and Drug Administration (U.S. FDA).
Highlights of prescribing information, Vabysmo. 2022. [Internet;
cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
[6] Heier JS, et al. Efficacy, durability, and safety of
intravitreal faricimab up to every 16 weeks for neovascular macular
degeneration (nAMD) (TENAYA and LUCERNE): two randomised,
double-masked, Phase III, non-inferiority trials. The Lancet. 2022;
399:729-40.
[7] Medicines and Healthcare products Regulatory Agency approves
faricimab through international work-sharing initiative. [Internet;
cited July 2024]. Available from:
https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
[8] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with nAMD (TENAYA). [Internet;
cited July 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT03823287.
[9] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with nAMD (LUCERNE). [Internet;
cited July 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT03823300.
[10] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with DME (YOSEMITE). [Internet;
cited July 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT03622580.
[11] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with DME (RHINE). [Internet;
cited July 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT03622593.
[12]Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with macular edema secondary to
branch RVO (BALATON). [Internet; cited July 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740905.
[13] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with macular edema secondary to
central retinal or hemi RVO (COMINO). [Internet; cited July 2024].
Available from:
https://clinicaltrials.gov/ct2/show/NCT04740931.
[14] United States National Institutes of Health - National Eye
Institute. Macular edema. 2023. [Internet; cited July 2024].
Available from:
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema.
[15] Chugai obtains regulatory approval for Vabysmo, the first
bispecific antibody in ophthalmology, for nAMD and DME. [Internet;
cited July 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[16] Chugai obtains regulatory approval for Vabysmo, the only
bispecific antibody in the ophthalmology field, for additional
indication of macular edema associated with RVO. [Internet; cited
July 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[17] European Medicines Agency. Summary of product characteristics,
Vabysmo. 2022. [Internet; cited July 2024]. Available from:
https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[18] Roche data on file.
[19] Wykoff C, et al. Efficacy, durability, and safety of
intravitreal faricimab with extended dosing up to every 16 weeks in
patients with DME (YOSEMITE and RHINE): two randomised,
double-masked, Phase III trials. The Lancet. 2022; 399:741-755.
[20] U.S. FDA. Highlights of prescribing information, Susvimo.
2021. [Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
[21] U.S. FDA. Highlights of prescribing information, Lucentis.
2014. [Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.
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