{"id":48572,"date":"2022-09-20T13:01:40","date_gmt":"2022-09-20T11:01:40","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/alnylam-receives-approval-in-europe-for-amvuttra-vutrisiran-for-the-treatment-of-hereditary-transthyretin-mediated-hattr-amyloidosis-in-adult-patients-with-stage-1-or-stage-2-polyneuropathy\/"},"modified":"2022-09-20T13:01:40","modified_gmt":"2022-09-20T11:01:40","slug":"alnylam-receives-approval-in-europe-for-amvuttra-vutrisiran-for-the-treatment-of-hereditary-transthyretin-mediated-hattr-amyloidosis-in-adult-patients-with-stage-1-or-stage-2-polyneuropathy","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/alnylam-receives-approval-in-europe-for-amvuttra-vutrisiran-for-the-treatment-of-hereditary-transthyretin-mediated-hattr-amyloidosis-in-adult-patients-with-stage-1-or-stage-2-polyneuropathy\/","title":{"rendered":"Alnylam Receives Approval in Europe for AMVUTTRA\u00ae (vutrisiran) for the Treatment of Hereditary Transthyretin-mediated (hATTR) Amyloidosis in Adult Patients with Stage 1 or Stage 2 Polyneuropathy"},"content":{"rendered":"
\n

\n\u2013 AMVUTTRA Demonstrated Halting or Reversal in Neuropathy Impairment with Subcutaneous Administration Once Every Three Months \u2013<\/i>\n<\/p>\n

\n\u2013 Decision Follows Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2022 \u2013<\/i>\n<\/p>\n

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc.<\/a> (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the European Commission (EC) has granted marketing authorization for AMVUTTRA\u00ae<\/sup> (vutrisiran), an RNAi therapeutic for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy. The EC approval is based on positive 18-month results from the HELIOS-A Phase 3 study, where AMVUTTRA significantly improved the signs and symptoms of hATTR amyloidosis, with more than 50 percent of patients experiencing halting or reversal of their polyneuropathy manifestations.\n<\/p>\n

<\/a><\/p>\n

\n\u201cOn behalf of patients across Europe, we could not be prouder to announce the approval of AMVUTTRA, our second RNAi therapeutic for hATTR amyloidosis. We are committed to delivering continued innovation to people affected by rare, life-limiting conditions where high unmet need still exists. Today\u2019s decision now means we can progress working with health authorities across Europe to achieve responsible and sustainable access arrangements that allow us to bring AMVUTTRA to patients as quickly as possible. Our thanks go to the patients, families, investigators and study staff who have enabled us to reach this significant milestone,\u201d said Kasha Witkos, SVP, Head International Region at Alnylam.\n<\/p>\n

\n\u201cAlthough the considerable research into hATTR amyloidosis over the past few years has resulted in a more positive outlook for those diagnosed with the condition, there remain unmet needs in treatment for patients living with this rapidly progressive, multi-system disease\u201d, said Professor David Adams, Head of the Neurology department at Bic\u00eatre hospital AP-HP, University of Paris-Saclay and Lead Investigator for the HELIOS-A Study. \u201cRNAi therapeutics are changing the future of medicine and I am honored to have contributed to these research efforts that have enabled us to bring an innovative new medicine to patients. Results from the HELIOS-A study have shown the potential AMVUTTRA has to benefit patients with hATTR amyloidosis with stage 1 or stage 2 polyneuropathy, whilst also helping reduce treatment burden through subcutaneous dosing once every three months.\u201d\n<\/p>\n

\nHELIOS-A was a global, randomized, open-label, multicenter, Phase 3 study that evaluated the efficacy and safety of AMVUTTRA across a diverse group of patients with hATTR amyloidosis with stage 1 or stage 2 polyneuropathy. Results of the HELIOS-A study were published in Amyloid<\/i> in July, 2022.\n<\/p>\n

\nIn the HELIOS-A study, AMVUTTRA met the primary and all secondary endpoints of the study at both 9 months<\/a> and 18 months<\/a>, demonstrating reversal in neuropathy impairment and an encouraging safety and tolerability profile. AMVUTTRA demonstrated improvement in the mean change from baseline in modified Neuropathy Impairment Score + 7 (mNIS+7) at 18 months (the primary endpoint for the EU), as compared to external placebo data from the landmark APOLLO Phase 3 study of patisiran.\n<\/p>\n

\nAfter 18 months of dosing, the most frequently occurring adverse reactions in AMVUTTRA-treated patients were arthralgia (joint stiffness) and pain in extremity (pain in arms and legs). Other less frequent adverse reactions reported with AMVUTTRA were <\/i>dyspnea (shortness of breath), injection site reaction and an increase in blood alkaline phosphatase (a liver enzyme).\n<\/p>\n

\nVutrisiran was previously granted Orphan Drug Designation in the European Union (EU) and U.S. for the treatment of ATTR amyloidosis and in Japan for transthyretin type familial amyloidosis with polyneuropathy. In June 2022, AMVUTTRA was approved by the U.S. Food and Drug Administration (FDA) for the treatment of the polyneuropathy of hATTR amyloidosis in adults. Vutrisiran is under review by the Brazilian Health Regulatory Agency (ANVISA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).\n<\/p>\n

\nAbout AMVUTTRA\u00ae <\/sup>(vutrisiran)<\/b>\n<\/p>\n

\nAMVUTTRA is an RNAi therapeutic, which is designed to target and silence specific messenger RNA (mRNA), blocking the production of wild-type and variant transthyretin (TTR) protein before it is made. AMVUTTRA utilizes Alnylam\u2019s Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate delivery platform, designed for increased potency and high metabolic stability to allow for quarterly, and potentially biannual, subcutaneous administration. Vutrisiran is also in development for the treatment of ATTR amyloidosis with cardiomyopathy, which encompasses both hereditary ATTR (hATTR) and wild-type ATTR (wtATTR) amyloidosis.\n<\/p>\n

\nAbout hATTR Amyloidosis<\/b>\n<\/p>\n

\nHereditary transthyretin-mediated (hATTR) amyloidosis is an inherited, progressively debilitating, and fatal disease caused by variants (i.e., mutations) in the TTR gene. TTR protein is primarily produced in the liver and is normally a carrier of vitamin A. Variants in the TTR gene cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory-motor neuropathy, autonomic neuropathy, and\/or cardiomyopathy, as well as other disease manifestations. hATTR amyloidosis represents a major unmet medical need with significant morbidity and mortality affecting approximately 50,000 people worldwide. The median survival is 4.7 years following diagnosis, with a reduced survival (3.4 years) for patients presenting with cardiomyopathy.\n<\/p>\n

\nAbout RNAi<\/b>\n<\/p>\n

\nRNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as \u201ca major scientific breakthrough that happens once every decade or so,\u201d and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam\u2019s RNAi therapeutic platform, function upstream of today\u2019s medicines by silencing messenger RNA (mRNA) \u2013 the genetic precursors \u2013 that encode for disease-causing proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.\n<\/p>\n

\nIMPORTANT SAFETY INFORMATION<\/b>\n<\/p>\n

\nReduced Serum Vitamin A Levels and Recommended Supplementation<\/span>\n<\/p>\n

\nAMVUTTRA treatment leads to a decrease in serum vitamin A levels. Supplementation of approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day is advised for patients taking AMVUTTRA. Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness).\n<\/p>\n

\nAdverse Reactions<\/span>\n<\/p>\n

\nThe most frequently occurring adverse reactions in patients treated with AMVUTTRA were arthralgia and pain in extremity. Other commonly reported adverse reactions with AMVUTTRA were dyspnoea, injection site reaction and increase in blood alkaline phosphatase.\n<\/p>\n

\nAbout Alnylam Pharmaceuticals<\/b>\n<\/p>\n

\nAlnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)\/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the potential treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam\u2019s has developed RNAi therapeutic products which are licensed for the treatment of hATTR amyloidosis, acute hepatic porphyria, primary hyperoxaluria type 1 and primary hypercholesterolemia \/ mixed dyslipidemia. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its \u201cAlnylam P5<\/sup>x25<\/i>\u201d strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA.\n<\/p>\n

\nAlnylam Forward Looking Statements<\/b>\n<\/p>\n

\nVarious statements in this release concerning Alnylam’s future expectations, plans and prospects, including, without limitation, Alnylam\u2019s views with respect to the safety and efficacy of AMVUTTRA, a quarterly subcutaneous injection, for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, the potential of AMVUTTRA to significantly improve the signs and symptoms of polyneuropathy, and potentially halt or reverse disease manifestations for some patients, the potential of AMVUTTRA to help reduce treatment burden through subcutaneous dosing once every three months, plans to progress working with health authorities across Europe to achieve responsible and sustainable access arrangements to bring AMVUTTRA to patients as quickly as possible, continued regulatory review of vutrisiran in multiple jurisdictions, and Alnylam\u2019s aspiration to become a leading biotech company and the planned achievement of its \u201cAlnylam P5<\/sup>x25<\/i>\u201d strategy, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation: the direct or indirect impact of the COVID-19 global pandemic or any future pandemic on Alnylam\u2019s business, results of operations and financial condition and the effectiveness or timeliness of Alnylam\u2019s efforts to mitigate the impact of the pandemic; the potential impact of the recent leadership transition on Alnylam\u2019s ability to attract and retain talent and to successfully execute on its \u201cAlnylam P5x25\u201d strategy; Alnylam’s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates; actions or advice of regulatory agencies and Alnylam\u2019s ability to obtain and maintain regulatory approval for its product candidates, including vutrisiran, as well as favorable pricing and reimbursement; successfully launching, marketing and selling its approved products globally, including AMVUTTRA; delays, interruptions or failures in the manufacture and supply of its product candidates or its marketed products; obtaining, maintaining and protecting intellectual property; Alnylam\u2019s ability to successfully expand the indication for ONPATTRO, AMVUTTRA and OXLUMO in the future; Alnylam’s ability to manage its growth and operating expenses through disciplined investment in operations and its ability to achieve a self-sustainable financial profile in the future without the need for future equity financing; Alnylam\u2019s ability to maintain strategic business collaborations; Alnylam’s dependence on third parties for the development and commercialization of certain products, including Novartis, Sanofi, Regeneron and Vir; the outcome of litigation; the potential impact of current and the risk of future government investigations; and unexpected expenditures; as well as those risks more fully discussed in the \u201cRisk Factors\u201d filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in its other SEC filings. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nAlnylam Pharmaceuticals, Inc.<\/b>\n<\/p>\n

\nChristine Regan Lindenboom
\n
(Investors and Media)
\n
+1-617-682-4340\n<\/p>\n

\nJosh Brodsky
\n
(Investors)
\n
+1-617-551-8276\n<\/p>\n

\nEmily Bunting
\n
(Media, Europe)
\n
+41 79 866 97 03\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u2013 AMVUTTRA Demonstrated Halting or Reversal in Neuropathy Impairment with Subcutaneous Administration Once Every Three Months \u2013 \u2013 Decision Follows Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2022 \u2013 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48572","6":"format-standard","7":"category-industry"},"yoast_head":"\nAlnylam Receives Approval in Europe for AMVUTTRA\u00ae (vutrisiran) for the Treatment of Hereditary Transthyretin-mediated (hATTR) Amyloidosis in Adult Patients with Stage 1 or Stage 2 Polyneuropathy - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/alnylam-receives-approval-in-europe-for-amvuttra-vutrisiran-for-the-treatment-of-hereditary-transthyretin-mediated-hattr-amyloidosis-in-adult-patients-with-stage-1-or-stage-2-polyneuropathy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alnylam Receives Approval in Europe for AMVUTTRA\u00ae (vutrisiran) for the Treatment of Hereditary Transthyretin-mediated (hATTR) Amyloidosis in Adult Patients with Stage 1 or Stage 2 Polyneuropathy - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"\u2013 AMVUTTRA Demonstrated Halting or Reversal in Neuropathy Impairment with Subcutaneous Administration Once Every Three Months \u2013 \u2013 Decision Follows Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2022 \u2013 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. 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