FDA accepts application for Roche’s Vabysmo for the treatment of
retinal vein occlusion (RVO)
- Acceptance based on two
phase III studies that demonstrated early and sustained vision
improvement with Vabysmo, meeting primary endpoint of
non-inferiority compared to aflibercept
- Application was further
supported by data showing Vabysmo achieved rapid and robust drying
of retinal fluid
- If approved, RVO would be
the third indication for Vabysmo in addition to neovascular or
‘wet’ age-related macular degeneration (nAMD) and diabetic macular
edema (DME)
- Vabysmo is currently
approved in 60 countries to treat nAMD and DME, with nearly one
million doses distributed globally
Basel, 9 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced
today that the U.S. Food and Drug Administration (FDA) has accepted
the company’s supplemental Biologics License Application (sBLA) for
Vabysmo® (faricimab) for the treatment of macular edema following
retinal vein occlusion (RVO). The sBLA is based on results from the
phase III BALATON and COMINO studies that demonstrated treatment
with Vabysmo provided early and sustained improvement in vision,
meeting the primary endpoint of non-inferior visual acuity gains at
24 weeks compared to aflibercept.1,2 Vabysmo’s safety profile was
consistent with previous trials.
“This acceptance brings us one step closer to delivering Vabysmo
as a treatment for retinal vein occlusion, a disease that affects
more than one million people in the United States and can cause
severe and sudden vision loss,” said Levi Garraway, M.D., Ph.D.,
Roche’s Chief Medical Officer and Head of Global Product
Development. “If approved, this would be the third indication for
Vabysmo, the first bispecific antibody available for the treatment
of retinal conditions that can cause blindness.”
The data from the BALATON and COMINO studies will be submitted
to other health authorities around the world, including the
European Medicines Agency, for approval for the treatment of
macular edema following RVO. The studies are ongoing, and data from
weeks 24 to 72 will assess the potential of Vabysmo to extend
dosing intervals up to every four months.1,2
Vabysmo is the first bispecific antibody approved for the eye
and was approved in the United States for the treatment of
neovascular or ‘wet’ age-related macular degeneration (nAMD) and
diabetic macular edema (DME) in January 2022.3 Vabysmo has also
been approved in 60 countries around the world, including Japan,
the United Kingdom and in the European Union for people living with
nAMD and DME.3-7 Neovascular AMD, DME and RVO together affect
around 70 million people worldwide and are among the leading causes
of vision loss.8-12
Vabysmo’s efficacy and safety profile in nAMD and DME is
supported by four large, global studies involving more than 3,000
participants and extensive real-world experience, with nearly one
million Vabysmo doses distributed globally.7,13-16 Vabysmo is the
first bispecific antibody approved for the eye with phase III
studies supporting treatment intervals of up to four months for
people with these conditions.4 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).13,14
About the BALATON and COMINO
studies1,2BALATON (NCT04740905) and
COMINO (NCT04740931) are two randomised, multicentre,
double-masked, global phase III studies evaluating the efficacy and
safety of Vabysmo® (faricimab) compared to aflibercept. For the
first 20 weeks, patients are randomised 1:1 to receive six monthly
injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From
weeks 24 to 72, all patients receive Vabysmo (6.0 mg) up to every
four months – according to a personalised treatment interval dosing
regimen – using a treat-and-extend approach.
The BALATON study is being conducted in 553 patients with branch
retinal vein occlusion. The COMINO study is being conducted in 729
patients with central retinal or hemiretinal vein occlusion.
The primary endpoint of each study is the change in
best-corrected visual acuity from baseline at 24 weeks. Secondary
endpoints include change in central subfield thickness (CST) from
baseline over time up to 24 weeks.
Both studies met the primary endpoint, with Vabysmo showing
non-inferior visual acuity gains compared to aflibercept. The
average vision gains from baseline were comparable between the two
treatments in both studies. In BALATON, vision gains were +16.9 eye
chart letters in the Vabysmo arm and +17.5 letters in the
aflibercept arm at 24 weeks. In COMINO, vision gains were +16.9
letters in the Vabysmo arm and +17.3 letters in the aflibercept arm
at 24 weeks.
A secondary endpoint showed that Vabysmo achieved rapid and
robust drying of retinal fluid, as measured by reduction in CST
from baseline. In both studies, reductions in CST were comparable
across treatment arms. In BALATON, CST reductions from baseline at
24 weeks were 311.4 μm in the Vabysmo arm and 304.4 μm in the
aflibercept arm. In COMINO, CST reductions from baseline at 24
weeks were 461.6 μm in the Vabysmo arm and 448.8 μm in the
aflibercept arm.
Additionally, both studies showed that more Vabysmo patients had
an absence of blood vessel leakage in the retina compared to
aflibercept patients as seen in a pre-specified exploratory
endpoint. Blood vessel leakage in the macula may lead to more
retinal fluid, which can cause swelling and blurry vision.
In BALATON, one-third of patients (34%) treated with Vabysmo had
an absence of macular leakage compared to one-fifth (21%) of
aflibercept patients at 24 weeks. In COMINO, the rates were 44% for
Vabysmo patients versus 30% for aflibercept patients at 24
weeks.
In both studies, Vabysmo’s safety profile was consistent with
previous trials. The most common adverse reaction was conjunctival
haemorrhage (3%). Safety results were consistent across study
arms.
The studies are ongoing, and data from weeks 24 to 72 will
assess the potential of Vabysmo to extend dosing intervals up to
every four months.
About retinal vein occlusion (RVO)RVO is the
second most common cause of vision loss due to retinal vascular
diseases. It affects an estimated 28 million adults globally,
mainly those aged 60 or older, and can lead to severe and sudden
vision loss.8,17 RVO typically results in sudden, painless vision
loss in the affected eye because the vein blockage restricts normal
blood flow in the affected retina, resulting in ischaemia,
bleeding, fluid leakage and retinal swelling called macular edema.
Currently, macular edema due to RVO is typically treated with
repeated intravitreal injections of anti-vascular endothelial
growth factor therapies.19 There are two main types of RVO: branch
RVO, which affects more than 23 million people globally and occurs
when one of the four smaller ‘branches’ of the main central retinal
vein becomes blocked; and central RVO, which is less common,
affecting more than four million people worldwide, and occurs when
the eye’s central retinal vein becomes blocked.8,19
About the Vabysmo® (faricimab) clinical development
programme Roche has a robust phase III clinical
development programme for Vabysmo. The programme includes
AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the
long-term safety and tolerability of Vabysmo in neovascular or
‘wet’ macular degeneration (nAMD), and Rhone-X, an extension study
of YOSEMITE and RHINE evaluating the long-term safety and
tolerability of Vabysmo in diabetic macular edema (DME).20,21 In
addition, Roche is investigating the efficacy and safety of Vabysmo
in people with macular edema following retinal vein occlusion (RVO)
in two phase III studies, BALATON and COMINO.1,2 Roche has also
initiated several phase IV studies, including the ELEVATUM study of
Vabysmo in underrepresented patient populations with DME, the
SALWEEN study of Vabysmo in a subpopulation of nAMD highly
prevalent in Asia, as well as the VOYAGER study, a global
real-world data collection platform.22-24 Roche also supports
several other independent studies to further understand retinal
conditions with a high unmet need.7
About Vabysmo® (faricimab)Vabysmo is the first
bispecific antibody approved for the eye.3,5 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.13,14 By blocking pathways
involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood
vessels.13,14 Vabysmo is approved in 60 countries around the world,
including the United States, Japan, the United Kingdom and in the
European Union for people living with neovascular or ‘wet’
age-related macular degeneration and diabetic macular edema. Review
by other regulatory authorities is ongoing.3-7
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 for
geographic atrophy and other vision-threatening diseases, including
rare and inherited conditions.
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 is
the first U.S. Food and Drug Administration-approved refillable eye
implant for neovascular or ‘wet’ age-related macular degeneration
that continuously delivers a customised formulation of ranibizumab
over a period of months.25 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 (Ang-2) and vascular endothelial growth factor-A
(VEGF-A).3,5,13,14 Lucentis®* (ranibizumab injection) is the first
treatment approved to improve vision in people with certain retinal
conditions.26
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 endeavor 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 thirteenth 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] Clinical Trials.gov. A study
to evaluate the efficacy and safety of faricimab in participants
with macular edema secondary to branch retinal vein occlusion
(BALATON) [Internet; cited April 2023]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740905. [2] Clinical
Trials.gov. A study to evaluate the efficacy and safety of
faricimab in participants with macular edema secondary to central
retinal or hemiretinal vein occlusion (COMINO) [Internet; cited
April 2023]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740931.[3] United States
Food and Drug Administration (U.S. FDA). Highlights of prescribing
information, Vabysmo. 2022 [Internet; cited April 2023]. Available
from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.[4]
European Medicines Agency. Summary of Product Characteristics,
Vabysmo, 2022 [Internet; cited April 2023]. Available from:
https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.[5]
Medicines and Healthcare products Regulatory Agency (MHRA). MHRA
approves faricimab through international work-sharing initiative
[Internet; cited April 2023]. Available from:
https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
[6] Chugai Pharmaceutical Co. Ltd. Chugai obtains regulatory
approval for Vabysmo, the first bispecific antibody in
ophthalmology, for nAMD and DME [Internet; cited April 2023].
Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[7] Roche data on file.[8] 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;9:010427.[9] Joussen AM, et al. Angiopoietin/Tie2 signalling
and its role in retinal and choroidal vascular diseases: a review
of preclinical data. Eye. 2021;35:1305-1316.[10] Yau JWY, et al.
Global prevalence and major risk factors of diabetic retinopathy.
Diabetes Care. 2012;35:556–64.[11] Connolly E, et al. Prevalence of
age-related macular degeneration associated genetic risk factors
and four-year progression data in the Irish population. Br J
Ophthalmol. 2018;102:1691-95.[12] Bright Focus Foundation.
Age-related macular degeneration: facts and figures [Internet;
cited April 2023]. Available from:
https://www.brightfocus.org/macular/article/age-related-macular-facts-figures [13]
Heier JS, et al. Efficacy, durability, and safety of intravitreal
faricimab up to every 16 weeks for neovascular age-related macular
degeneration (nAMD) (TENAYA and LUCERNE): two randomised,
double-masked, phase III, non-inferiority trials. The Lancet. 2022;
399:729-740.[14] Wykoff C, et al. Efficacy, durability and safety
of intravitreal faricimab with extended dosing up to every 16 weeks
in patients with diabetic macular edema (DME) (YOSEMITE and RHINE):
two randomised, double-masked, phase III trials. The Lancet. 2022;
399:741-755.[15] Wells JA, et al. Faricimab in DME: two-year
results from the phase III YOSEMITE and RHINE trials. Presented at:
Angiogenesis, Exudation and Degeneration 2022; 11-12 February 2022;
virtual.[16] Khanani A, et al. Faricimab in nAMD: year 2 efficacy,
safety and durability results from the phase III TENAYA and LUCERNE
trials. Presented at: 2022 American Society of Retina Specialists
Annual Scientific Meeting; 13-16 July 2022; New York City, NY,
USA.[17] Moorfields Eye Hospital, United Kingdom National Health
Service Foundation Trust. RVO [Internet; cited April 2023].
Available from:
https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion.[18]
Schmidt-Erfurth U, et al. Guidelines for the Management of Retinal
Vein Occlusion by the European Societyof Retina Specialists
(EURETINA). Ophthalmologica. 2019;242:123-162. [19] Campochiaro P.
Molecular pathogenesis of retinal and choroidal vascular diseases.
Prog Retin Eye Res. 2015;49:67-81.[20] Clinical Trials.gov. A study
to evaluate the long-term safety and tolerability of Vabysmo in
participants with nAMD (AVONELLE-X) [Internet; cited April 2023].
Available from: https://clinicaltrials.gov/ct2/show/NCT04777201.
[21] Clinical Trials.gov. A study to evaluate the long-term safety
and tolerability of Vabysmo in participants with DME (Rhone-X)
[Internet; cited April 2023]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04432831.[22] Clinical
Trials.gov. A study to investigate faricimab treatment response in
treatment-naïve, underrepresented patients with DME (ELEVATUM).
[Internet; cited April 2023]. Available from:
https://clinicaltrials.gov/ct2/show/NCT05224102. [23] APVRS. Design
and Rationale of the SALWEEN Trial: A Phase 3b/4 Study of
Faricimab, a Dual Angiopoietin-2 and Vascular Endothelial Growth
Factor-A Inhibitor, in Patients With Polypoidal Choroidal
Vasculopathy. [Internet; cited April 2023]. Available from:
https://2022.apvrs.org/abstract/?code=200351. [24] Clinical
Trials.gov. A Real-World Study to Gain Clinical Insights Into Roche
Ophthalmology Products (VOYAGER). [Internet; cited April 2023].
Available from:
https://clinicaltrials.gov/ct2/show/NCT05476926.[25] U.S. FDA.
Highlights of prescribing information, Susvimo. 2006 [Internet;
cited April 2023]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
[26] U.S. FDA. Highlights of prescribing information, Lucentis.
2006 [Internet; cited April 2023]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf.
Roche Group Media RelationsPhone: +41 61 688
8888 / e-mail: media.relations@roche.com
Hans Trees, PhDPhone: +41 79 407
72 58 |
Nathalie
AltermattPhone: +41 79 771 05 25 |
Karsten
KleinePhone: +41 79 461 86 83 |
Nina
MählitzPhone: +41 79 327 54 74 |
Kirti
PandeyPhone: +49 172 6367262 |
Dr.
Barbara von SchnurbeinPhone: +41 79 699 97 44 |
|
|
Sileia
Urech Phone: +41 79 935 81 48 |
|
|
|
Roche Investor Relations
Dr. Bruno
Eschli Phone: +41 61 68-75284 e-mail:
bruno.eschli@roche.com |
Dr.
Sabine BorngräberPhone: +41 61 68-88027 e-mail:
sabine.borngraeber@roche.com |
Dr.
Birgit MasjostPhone: +41 61 68-84814e-mail:
birgit.masjost@roche.com |
Dr.
Gerard Tobin Phone: +41 61 68-72942 e-mail:
gerard.tobin@roche.com |
Investor Relations North America
Loren
KalmPhone: +1 650 225 3217 e-mail:
kalm.loren@gene.com |
|
- 09052023_MR_FDAacceptanceVabysmo_en
Roche (LSE:0QQ6)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Roche (LSE:0QQ6)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024