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Find Clinical Drug Pipeline Developments & Deals by Alnylam Pharmaceuticals
The new agreement will allow Alnylam to utilize Medison's unique multi-regional platform to ensure that Alnylam's innovative RNAi therapeutics, such as ONPATTRO (patisiran), GIVLAARI (givosiran), and OXLUMO (lumasiran) are made available across additional countries in Europe.
Onpattro (patisiran) is a double-stranded siRNA that causes degradation of mutant and wild-type TTR mRNA through RNA interference resulting in reduction of serum TTR protein and TTR protein deposits in tissues. It is being developed for cardiomyopathy of ATTR amyloidosis.
ALN-KHK is an investigational, subcutaneously administered RNAi therapeutic targeting ketohexokinase for the treatment of Type 2 diabetes mellitus (T2DM). The safety and efficacy of ALN-KHK have not been evaluated by the FDA, EMA, Health Canada, or any other health authority.
ONPATTRO (patisiran) is an RNAi therapeutic that is approved in the United States and Canada for the treatment of the polyneuropathy of hATTR amyloidosis in adults. It is designed to target and silence TTR messenger RNA, thereby reducing the production of TTR protein.
FDA approval is based on results from the ILLUMINATE-C Phase 3 study, in which OXLUMO (lumasiran) treatment resulted in substantial reductions in POx and demonstrated encouraging safety and tolerability profile in patients with compromised renal function.
The 12-month findings across a comprehensive set of exploratory endpoints suggest that treatment with Onpattro (patisiran) was associated with favorable impacts on key measures of cardiac stress and injury, NT-proBNP and Troponin I.
AMVUTTRA (vutrisiran sodium) is an RNAi therapeutic, which target and silence specific mRNA, blocking the production of wild-type and variant transthyretin protein before it is made. In the HELIOS-A study, AMVUTTRA met all endpoints of the study at both 9 months and 18 months.
ALN-HSD was associated with robust target knockdown and numerically lower liver enzymes and biopsy-derived NAFLD Activity Score (NAS) over six months in patients receiving ALN-HSD relative to placebo.
ALN-HSD has exhibited an encouraging safety and tolerability profile to date; most common treatment-emergent
adverse event in healthy subjects treated with ALN-HSD was injection site reaction in five patients; all injection site reactions were mild in severity.
ONPATTRO (patisiran) is an intravenously administered RNAi therapeutic targeting transthyretin (TTR). It is designed to target and silence TTR messenger RNA, thereby reducing the production of TTR protein before it is made.
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