{"id":49349,"date":"2021-09-02T06:00:53","date_gmt":"2021-09-02T06:00:53","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=78155"},"modified":"2021-09-02T06:00:53","modified_gmt":"2021-09-02T06:00:53","slug":"orphalan-announces-fda-acceptance-for-filing-of-new-drug-application-nda-for-trientine-tetrahydrochloride-teta-4hcl-for-the-treatment-of-wilsons-disease","status":"publish","type":"post","link":"https:\/\/malaysiantribune.com\/orphalan-announces-fda-acceptance-for-filing-of-new-drug-application-nda-for-trientine-tetrahydrochloride-teta-4hcl-for-the-treatment-of-wilsons-disease\/","title":{"rendered":"Orphalan announces FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson\u2019s Disease"},"content":{"rendered":"
\n

Orphalan announces FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson\u2019s Disease<\/p>\n

\u2014<\/em>NDA <\/em>s<\/em>upported by <\/em>p<\/em>ositive <\/em>d<\/em>ata <\/em>from<\/em> Phase 3 CHELATE<\/em> clinical<\/em> trial<\/em><\/p>\n

\u2014<\/em>\u00a0<\/em>TETA 4-HCl previously granted Orphan Drug Designation for first-line treatment of Wilson\u2019s <\/em>D<\/em>isease<\/em><\/p>\n

Paris, Franc<\/strong>e \u2013 2\u00a0<\/strong>September<\/strong> 2021<\/strong> \u2013 Orphalan SA, a Company that identifies, develops and delivers worldwide therapies for orphan diseases, today announces that the US Food and Drug Administration (FDA) has accepted for review the Company\u2019s New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilson\u2019s Disease.<\/p>\n

Wilson\u2019s Disease is a rare inherited disorder of copper transport primarily affecting the liver and brain, affecting about 1 in every 30,000 people worldwide. TETA 4HCl is proposed as an alternative copper chelating agent to d-Penicillamine, the only approved first-line treatment of Wilson\u2019s Disease for the last 70 years, to which about a third of patients develop intolerance.<\/p>\n

The Company\u2019s NDA submission follows its previous Orphan Drug Designation by the FDA. The filing is based upon positive data from the CHELATE Phase 3 clinical trial<\/a> that met its primary efficacy endpoint by demonstrating that TETA 4HCl was non-inferior to d-Penicillamine as measured by copper speciation evaluation of non-ceruloplasmin copper (NCC).<\/p>\n

Treatment with TETA 4HCl is supported by Orphalan\u2019s novel NCC assay, for which the Company plans to file for FDA approval as a companion diagnostic. The in vitro NCC assay has the potential to provide an important additional tool to support physicians in identifying patients and monitoring their treatment with TETA 4HCl.<\/p>\n

Dr Naseem Amin, Chief Executive Officer at Orphalan<\/strong>, comment<\/strong>ed<\/strong>:<\/strong> \u201c<\/em>The FDA\u2019s acceptance of <\/em>the<\/em> NDA <\/em>brings us one step closer to<\/em> providing first<\/em>–<\/em>line treatment to<\/em> patients with Wilson\u2019s Disease<\/em>,<\/em> who <\/em>currently <\/em>do not benefit from alternative<\/em> methods of treatment<\/em>, <\/em>beyond D-<\/em>Penicillamine <\/em>\u201d<\/em>.<\/em><\/p>\n

Notes to Editors<\/u><\/strong><\/p>\n

About the CHELATE Study<\/strong><\/p>\n

CHELATE was a Phase 3, multicentre, randomised, open label, active-controlled, non-inferiority study conducted in 9 countries at 15 centres designed to evaluate efficacy and safety of trientine tetrahydrochloride compared to d-Penicillamine in patients with stable Wilson\u2019s Disease. Fifty-three adult Wilson\u2019s Disease patients with clinically stable disease for over one year and who met specific inclusion criteria, including laboratory measures of serum non-ceruloplasmin copper (NCC), 24-hour urinary copper excretion (UCE) and liver function tests, were followed for a baseline period for 12 weeks before being randomised 1:1 to either trientine tetrahydrochloride or d-Penicillamine twice daily. The study\u2019s primary endpoint was serum NCC as measured using Orphalan\u2019s proprietary method using copper speciation at 24-weeks post-randomisation. A secondary composite efficacy endpoint was NCC and 24-hour UCE.<\/p>\n

Additional secondary endpoints included were: clinical Global Impression of Change (CGIC) score; serum copper and ceruloplasmin levels; the unified Wilson\u2019s Disease Rating Scale (UWDRS); modified Nazer score; cognitive assessments and standard safety assessments. In addition, an independent adjudication committee blinded to the allocated treatment, and study centres assessed key efficacy and safety parameters to determine clinical stability of the patient. Trientine tetrahydrochloride was well tolerated and during treatment, more patients achieved the pre-specified composite endpoint of NCC and 24-hour Urinary Copper Excretion (UCE) within therapeutic target ranges, compared to patients treated with d-Penicillamine, 50% versus 24%. Data from the trial was presented during an oral presentation at EASL\u2019s The International Liver Congress\u2122 2021.<\/p>\n

About Orphalan<\/strong>
\nAt Orphalan, our mission is clear: we are pioneers in orphan diseases. Orphalan identifies, develops and delivers worldwide innovative therapies for people living with Orphan diseases. Orphalan was founded in 2011 and\u00a0has launched Cuprior\u2122 across Europe with its own commercial organisation.\u00a0For more information, visit www.orphalan.health<\/a> and follow us on LinkedIn<\/a>.<\/p>\n

For more information, please contact<\/strong>:\u00a0<\/strong><\/p>\n

Orphalan<\/strong>
\nTel: +33 (0)1 42 49 82 64
\ninfo@orphalan.health<\/a><\/p>\n

Consilium Strategic Communications:\u00a0<\/strong>
\nMary-Jane Elliott, Allison Connolly, Genevieve Wilson
\nTel: +44 (0) 203 709 5700
\norphalan@consilium-comms.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Orphalan announces FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson\u2019s Disease \u2014NDA supported by positive data from Phase 3 CHELATE clinical trial \u2014\u00a0TETA 4-HCl previously granted Orphan Drug Designation for first-line treatment of Wilson\u2019s Disease Paris, France \u2013 2\u00a0September 2021 \u2013 Orphalan SA, a [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"yoast_head":"\nOrphalan announces FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson\u2019s Disease - Malaysian Tribune<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/malaysiantribune.com\/orphalan-announces-fda-acceptance-for-filing-of-new-drug-application-nda-for-trientine-tetrahydrochloride-teta-4hcl-for-the-treatment-of-wilsons-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Orphalan announces FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson\u2019s Disease - 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