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R&D Trends: Anticoagulants for stroke prevention in atrial fibrillation - Upcoming heavy hitters leave a permanent mark
Datamonitor, Nov 2011, Pages: 38
With Pradaxa (dabigatran) and Xarelto (rivaroxaban) approved for stroke prevention in atrial fibrillation and two other candidates well on their way towards the market, development activity in this arena is at a cross-roads. Such is the likely transformation in care represented by these four products that development strategies are already fundamentally changing.
Features and benefits
- Key elements of clinical trial strategy and design for anticoagulant products targeting stroke prevention in atrial fibrillation
- Overview of late stage clinical pipeline, recent discontinuations and the nature of future candidates
- Analysis of target and minimum acceptable product profiles as compared to current standards of care
Highlights
- Anticoagulant pipeline casualties have historically been clinically driven, however, there is evidence that pipeline discontinuations are increasingly being driven by commercial decision making. Developers now face a decision between pursuing costly mega-trial strategies and high risk niche strategies offering few guaranteed returns.
- Very few companies have the resources to fund increasingly complex, expansive trials. Fewer will be inclined to perform these trials as four breakthrough products vie for share. Niche sub-sectors may offer alternative opportunities but may still require assessment against new products for which clear roles are far from established or accepted.
- Datamonitor predicts a hiatus in the aggressive hunt for warfarin alternatives until the current crop are better integrated into clinical practice. This could take years, and is likely to be followed by a wave of me-too products and the systematic fragmentation of the market by competitors seeking to isolate high value patient subgroups.
Your key questions answered
- Understand the factors driving the shape of clinical trial strategies for the current crop of new market entrants
- Predict the likely impact of four breakthrough products on trial strategy and design in stroke prevention
- Identify the prerequisites for the would-be new market entrants of the future
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