Blog Exposure - CHMP Adopts Positive Opinion for Alnylam’s Patisiran for HATTR Amyloidosis Treatment
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LONDON, UK / ACCESSWIRE / July 31, 2018 / If you want access to our free research report on Alnylam Pharma, Inc. (NASDAQ: ALNY), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ALNY as the Company's latest news hit the wire. On July 27, 2018, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended a positive opinion recommending marketing authorization of patisiran for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or stage 2 polyneuropathy. If approved by the European Commission (EC), the medicine will be commercialized under the brand name ONPATTRO™. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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SmPC Recommended by CHMP Includes Data from APOLLO Primary and Secondary Endpoints
The CHMP's positive opinion is based on the evaluation of the effects of patisiran in patients with hATTR amyloidosis and its safety profile as demonstrated in the APOLLO Phase-3 study. In APOLLO, the safety and efficacy of patisiran were evaluated in a diverse, global population of hATTR amyloidosis patients. The study showed that patisiran improved measures of polyneuropathy, quality of life, activities of daily living, ambulation, nutritional status, and autonomic symptoms relative to placebo in adult patients with hATTR amyloidosis. The SmPC recommended by the CHMP includes data from APOLLO primary and secondary endpoints, as well as exploratory cardiac endpoints. The results of the APOLLO study were published on July 05, 2018, in the New England Journal of Medicine (NEJM).
EC Will Review the CHMP's Recommendation to Deliver its Final Decision
The European Medicines Agency (EMA) reviewed patisiran under the accelerated assessment procedure that is granted to medicines that the CHMP believes are of major interest for public health and therapeutic innovation. A CHMP positive opinion is one of the final steps before marketing authorization is granted by the EC. The EC will now review the CHMP recommendation to deliver its final decision, applicable to all 28 EU member states, plus Iceland, Liechtenstein, and Norway.
Patisiran is Currently Under Priority Review as a Breakthrough Therapy with the FDA
On February 01, 2018, the US Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) for patisiran for the treatment of hATTR amyloidosis. The FDA also granted Alnylam's request for Priority Review and has set an action date of August 11, 2018, under the Prescription Drug User Fee Act (PDUFA). Patisiran has been granted a Fast Track Designation, a Breakthrough Therapy Designation, and an expanded Orphan Drug Designation for ATTR amyloidosis from the FDA. Regulatory filings in other markets for patisiran, including Japan, are planned for mid-2018.
About Hereditary ATTR Amyloidosis
Hereditary ATTR (hATTR) amyloidosis is an inherited, progressive disease caused by a genetic mutation that results in the misfolding of transthyretin (TTR) proteins. This results in the formation of amyloid fibrils that could deposit in the nerves, heart, and/or gastrointestinal (GI) tract. hATTR amyloidosis symptoms can vary from person to person, depending on which organs or tissues are affected, and can worsen as the disease progresses. Many people remain undiagnosed or misdiagnosed and treatment options for people with this disease are limited.
About Patisiran
Patisiran is an investigational, intravenously administered ribonucleic acid interference (RNAi) therapeutic targeting transthyretin (TTR) in development for the treatment of hereditary ATTR amyloidosis. It is designed to target and silence specific messenger RNA, potentially blocking the production of TTR protein before it is made. This may help to reduce the deposition and facilitate the clearance of TTR amyloid in peripheral tissues and potentially restore function to these tissues.
About Alnylam Pharmaceuticals, Inc.
Founded in 2002 and headquartered in Cambridge, Massachusetts, Alnylam is a biopharmaceutical organization developing novel therapeutics based on RNAi. The Company is leading the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics in three strategic therapeutic areas (STArs), namely: (i) genetic medicines, (ii) cardio-metabolic diseases, and (iii) hepatic infectious diseases.
Stock Performance Snapshot
July 30, 2018 - At Monday's closing bell, Alnylam Pharma's stock declined 7.37%, ending the trading session at $96.81.
Volume traded for the day: 1.31 million shares, which was above the 3-month average volume of 731.68 thousand shares.
Stock performance in the previous three-month period – up 2.41%; and past twelve-month period – up 17.16%
After yesterday's close, Alnylam Pharma's market cap was at $9.85 billion.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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