The Medicines Company/Alnylam’s Phase II inclisiran’s biannual dosing potential boosts hypercholesterolemia promise amid pending CVOT – experts

07 Dec 2016

The Medicines Company (NASDAQ:MDCO)/Alnylam Pharmaceuticals’ (NASDAQ:ALNY) Phase II PCSK9 inhibitor inclisiran’s biannual dosing potential could substantially boost its hypercholesterolemia uptake prospects over competitors, experts agreed. Amgen’s (NASDAQ:AMGN) Repatha (evolocumab) and Regeneron Pharmaceuticals’ (NASDAQ:REGN) Praluent’s (alirocumab) approximate fortnightly dosing schedules are both less attractive than inclisiran’s, they said.

Also PCSK9 inhibitors, Praluent and Repatha were FDA approved in July and August, respectively.

All experts noted confidence in inclisiran’s final read out success based on impressive interim outcomes.

Experts agreed PCSK9 inhibitor safety, including for inclisiran, isn’t a concern but were split regarding the likely class uptake impact of Repatha and Praluent’s cardiovascular outcome trial (CVOT), expected in 1Q17 and December 2017, respectively. Two experts argued CV outcomes are required to assess the clinical relevance of the PCSK9 inhibitors’ LDL-C reduction effects, whilst the other two experts maintained available data is sufficiently impressive for their prescription, though CVOT data may lessen payer pushback.

An analyst report predicts inclisiran’s sales could reach up to USD 1.3bn in 2030.

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