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Faricimab-svoa

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(A chain)
QVQLVQSGAE VKKPGASVKV SCKASGYTFT GYYMHWVRQA PGQGLEWMGW INPNSGGTNY
AQKFQGRVTM TRDTSISTAY MELSRLRSDD TAVYYCARSP NPYYYDSSGY YYPGAFDIWG
QGTMVTVSSA SVAAPSVFIF PPSDEQLKSG TASVVCLLNN FYPREAKVQW KVDNALQSGN
SQESVTEQDS KDSTYSLSST LTLSKADYEK HKVYACEVTH QGLSSPVTKS FNRGECDKTH
TCPPCPAPEA AGGPSVFLFP PKPKDTLMAS RTPEVTCVVV DVSHEDPEVK FNWYVDGVEV
HNAKTKPREE QYNSTYRVVS VLTVLAQDWL NGKEYKCKVS NKALGAPIEK TISKAKGQPR
EPQVCTLPPS RDELTKNQVS LSCAVKGFYP SDIAVEWESN GQPENNYKTT PPVLDSDGSF
FLVSKLTVDK SRWQQGNVFS CSVMHEALHN AYTQKSLSLS PGK
(B chain)
EVQLVESGGG LVQPGGSLRL SCAASGYDFT HYGMNWVRQA PGKGLEWVGW INTYTGEPTY
AADFKRRFTF SLDTSKSTAY LQMNSLRAED TAVYYCAKYP YYYGTSHWYF DVWGQGTLVT
VSSASTKGPS VFPLAPSSKS TSGGTAALGC LVKDYFPEPV TVSWNSGALT SGVHTFPAVL
QSSGLYSLSS VVTVPSSSLG TQTYICNVNH KPSNTKVDKK VEPKSCDKTH TCPPCPAPEA
AGGPSVFLFP PKPKDTLMAS RTPEVTCVVV DVSHEDPEVK FNWYVDGVEV HNAKTKPREE
QYNSTYRVVS VLTVLAQDWL NGKEYKCKVS NKALGAPIEK TISKAKGQPR EPQVYTLPPC
RDELTKNQVS LWCLVKGFYP SDIAVEWESN GQPENNYKTT PPVLDSDGSF FLYSKLTVDK
SRWQQGNVFS CSVMHEALHN AYTQKSLSLS PGK
(C chain)
DIQLTQSPSS LSASVGDRVT ITCSASQDIS NYLNWYQQKP GKAPKVLIYF TSSLHSGVPS
RFSGSGSGTD FTLTISSLQP EDFATYYCQQ YSTVPWTFGQ GTKVEIKRTV AAPSVFIFPP
SDEQLKSGTA SVVCLLNNFY PREAKVQWKV DNALQSGNSQ ESVTEQDSKD STYSLSSTLT
LSKADYEKHK VYACEVTHQG LSSPVTKSFN RGEC
(D chain)
SYVLTQPPSV SVAPGQTARI TCGGNNIGSK SVHWYQQKPG QAPVLVVYDD SDRPSGIPER
FSGSNSGNTA TLTISRVEAG DEADYYCQVW DSSSDHWVFG GGTKLTVLSS ASTKGPSVFP
LAPSSKSTSG GTAALGCLVK DYFPEPVTVS WNSGALTSGV HTFPAVLQSS GLYSLSSVVT
VPSSSLGTQT YICNVNHKPS NTKVDKKVEP KSC
(Disulfide bridge: A22-A96, A156-A216, A236-D213, A242-B232, A245-B235, A277-A337, A365-A441, B22-B96, B150-B206, B226-C214, B267-B327, B360-B431, B23-B88, B134-B194, D22-D87, D137-D193)

Faricimab

FormulaC6506H9968N1724O1026S45
CAS1607793-29-2
Mol weight130194.6203

Faricimab-svoa

FDA APPROVED 1/28/2022, Vabysmo

To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema

RO6867461

  • Faricimab
  • Faricimab [INN]
  • RG-7716
  • RG7716
  • RO-6867461
  • RO6867461
  • UNII-QC4F7FKK7I
  • WHO 10563
FDA Approves Faricimab for nAMD and Diabetic Macular Edema
EfficacyAngiogenesis inhibitor, Anti-angiopoietin 2 antibody, Anti-VEGF antibody
CommentAntibody
Opthamology indications in patients susceptible to blocking of vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2)

Faricimab, sold under the brand name Vabysmo, is a monoclonal antibody used for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).[1] Faricimab is a bispecific monoclonal antibody.[2]

Faricimab was developed by Roche. Faricimab completed Phase III trials[3] and was approved for use in the United States by the Food and Drug Administration in January 2022.[1][4]

FDA Approves Faricimab to Treat Wet AMD and DME\

FDA Approves Faricimab to Treat Wet AMD and DMEFebruary 1, 2022

Laura Joszt, MA

This represents the approval of the first bispecific antibody to treat wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

https://www.ajmc.com/view/fda-approves-fariximab-to-treat-wet-amd-and-dme

The FDA has approved faricimab-svoa (Vabysmo; Genentech) to treat 2 leading causes of vision loss: wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).

After 4 initial monthly doses, faricimab is delivered as injections from 1 to 4 months apart in the first year while the current standard of care for wet AMD and DME requires injections every 1 to 2 months. In wet AMD, patients receive the 4 monthly injections first and then based on outcomes may receive their subsequent treatments every 2, 3, or 4 months. For DME, after the 4 initial monthly injections, treatment is extended or reduced based on outcomes, with a range of 1 to 4 months between doses.

The treatment targets and inhibits pathways involving angiopoietin-2 and vascular endothelial growth factor-A (VEGF-A), which are thought to contribute to vision loss by destabilizing blood vessels.

“Vabysmo represents an important step forward for ophthalmology. It is the first bispecific antibody approved for the eye and a major advance in treating retinal conditions such as wet AMD and diabetic macular edema,” Charles Wykoff, MD, PhD, director of research at Retina Consultants of Texas in Houston and a Vabysmo phase 3 investigator, said in a statement. “With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”

The FDA approved faricimab on the results from 4 phase 3 studies: TENAYA and LUCERNE for wet AMD and YOSEMITE and RHINE for DME. All 4 studies were randomized, multicenter, double-masked, global trials.

TENAYA and LUCERNE were identical: 1329 treatment-naive patients with wet AMD, aged 50 and older, were assigned 1:1 to faricimab up to every 16 weeks or aflibercept every 8 weeks. YOSEMITE and RHINE were also identical: 1891 patients with vision loss due to DME were randomly assigned 1:1:1 to faricimab every 8 weeks, faricimab per personalized treatment interval, or aflibercept every 8 weeks.

For all trials, faricimab was noninferior to aflibercept and the incidence of ocular adverse events was comparable. The researchers determined that the longer time between dosing intervals combined with the visual benefits of faricimab reduced the burden in patients.

The 1-year results from these studies were published January 24 in The Lancet.1,2

“These data published in The Lancet reinforce the potential of faricimab as an important treatment option that may help improve and maintain vision while extending the time between treatments up to 4 months,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a statement. “We remain deeply committed to developing new medicines such as faricimab that may help preserve sight in many people living with serious retinal conditions.”

Now that faricimab is approved, Genentech expects it to become available in the United States within weeks. Meanwhile, the European Medicines Agency is currently evaluating a Marketing Authorization Application for faricimab to treat wet AMD and DME.

There are additional trials—COMINO and BALATON—underway to evaluate the efficacy and safety of faricimab in people with macular edema following retinal vein occlusion. In addition, 2-year results for faricimab in DME will be presented at the Angiogeneisis, Exudation, and Degeneration 2022 meeting in February.

References

1. Heier JS, Khanani AM, Quezada Ruiz C, et al; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. Published January 24, 2022. doi:10.1016/S0140-6736(22)00010-1

2. Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. Published online January 24, 2022. doi:10.1016/S0140-6736(22)00018-6

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/////////////////////////////////////////////////////////////////////////////

Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetVEGF-Aangiopoietin 2
Clinical data
Trade namesVabysmo
Other namesRO6867461; faricimab-svoa
License dataUS DailyMedFaricimab
ATC codeNone
Legal status
Legal statusUS: ℞-only
Identifiers
CAS Number1607793-29-2
UNIIQC4F7FKK7I
KEGGD11516
Chemical and physical data
FormulaC6506H9968N1724O1026S45
Molar mass130197.05 g·mol−1

Society and culture

Names

Faricimab is the International Nonproprietary Name (INN).[5]

References

  1. Jump up to:a b “FDA approves Roche’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss”Roche (Press release). 31 January 2022. Retrieved 31 January 2022.
  2. ^ Nicolò M, Ferro Desideri L, Vagge A, Traverso CE (March 2021). “Faricimab: an investigational agent targeting the Tie-2/angiopoietin pathway and VEGF-A for the treatment of retinal diseases”. Expert Opinion on Investigational Drugs30 (3): 193–200. doi:10.1080/13543784.2021.1879791PMID 33471572S2CID 231665201.
  3. ^ Khan M, Aziz AA, Shafi NA, Abbas T, Khanani AM (August 2020). “Targeting Angiopoietin in Retinal Vascular Diseases: A Literature Review and Summary of Clinical Trials Involving Faricimab”Cells9 (8): 1869. doi:10.3390/cells9081869PMC 7464130PMID 32785136.
  4. ^ “FDA approves faricimab for treatment of wet AMD, DME”. Ophthalmology Times. 28 January 2022.
  5. ^ World Health Organization (2018). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80”. WHO Drug Information32 (3). hdl:10665/330907.
  • “Faricimab”Drug Information Portal. U.S. National Library of Medicine.

////////////Faricimab-svoa, APPROVALS 2022, FDA 2022, RO6867461, RO 6867461, PEPTIDE, MONOCLONAL ANTIBODY, RG 7716, WHO 10563, peptide

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 PLUS year tenure till date June 2021, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 33 lakh plus views on New Drug Approvals Blog in 233 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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