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Will Next Generation Oral Anticoagulants Replace Warfarin as Mainstay Therapy?
MP Advisors, Aug 2011
Will Next Generation Oral Anticoagulants Replace Warfarin as Mainstay Therapy?
Pradaxa: With a first mover advantage, Will it be the Leader in SPAF?
Xarelto: Is it the future mainstay anticoagulant therapy?
Eliquis and Edoxaban: Would they be able to differentiate enough?
In the coming months, there are major regulatory and clinical milestones with regard to the new generation of oral anticoagulants (Pradaxa, Xarelto, Eliquis and Edoxaban), which will have wide ranging impact on the treatment paradigm in several therapeutic areas encompassing - stroke prevention in atrial fibrillation / DVT Treatment / VTE prevention in medically ill patients and Acute coronary syndrome.
Stroke prevention in atrial fibrillation (SPAF-Chronic therapy) is the largest potential market and we forecast upto $5b in peak sales for the new generation anticoagulants. SPAF affects about 4.5m people in the EU and 2.2m in the US. Existing clinical data on Pradaxa, Xarelto and Eliquis is not differentiated enough and as well not comparable due to differences in clinical trial design and endpoints. However upcoming milestones – new clinical data and regulatory decisions would largely fix the competitive landscape, which will eventually evolve based on physician experience, regulatory scenario and entry of new drugs. Among the other late stage pipeline candidates Daiichi's Edoxaban is most promising.
There are also other important pipeline drugs which are in early stage development and pose threat to the potential of Xarelto/Eliquis/Pradaxa in the longer term. In SPAF our forecast is driven by a number of factors which would influence the treatment decisions in the near term and longer term.
- Warfarin Genotype testing, its regulatory approval and its reimbursement
- Warfarin discontinuers
- Impact of dosing frequency on treatment practice in SPAF
- Patient's history of stroke and bleeding risk factors impacting treatment decision
- Concomitant Medicines- Affordability and drug-drug interaction
- Regulatory Scenario – Medicare Shared Saving program to be implemented in 2012
- Physician's Experience and cost effectiveness
Acute Coronary Syndrome (6 month therapy) – Does Xarelto has the potential to compete Brilinta?
ACS is the next largest potential market for the next generation anticoagulants, while Eliquis has failed in the PhIII ACS study on account of higher bleeding rates, but the ATLAS-TIMI trial exploring Xarelto is ongoing and data should be available by YE 2011. In the PhII trials, Xarelto has demonstrated robust clinical benefit over standard of care at both the doses (2.5mg - twice-daily & 5mg- twice-daily dose), which are currently being explored in Ph-III ATLAS-TIMI trial. We foresee Xarelto as a serious contender in the ACS space and should impact Brilinta potential. There are many ongoing trials, which will show data over the next two years and will have implications on the treatment paradigm in ACS.
VTE prevention in medically ill patients- Xarelto is unlikely to make it, Eliquis is the next one to watch out for (6 month therapy):
This represents about 55% of the Lovenox use and hence is a major opportunity for the next generation anticoagulants. Demonstrating benefit over Lovenox on efficacy in the medical prophylaxis setting, without increasing the risk of bleeding is a high hurdle. The data from ADOPT study exploring Eliquis in VTE prophylaxis in medically ill patients is around the corner, but in terms of expectations we remain on the sidelines due to efficacy concerns. Xarelto has failed in the MAGELLAN study, as increase in bleeding outweighed the benefit of reduction in clots.
DVT/PE treatment (3-12 month therapy):
This therapy represents a $3billion opportunity for the new generation anticoagulants. The DVT/PE treatment opportunity is not easy to guess, as the optimal duration of therapy is still a grey area. The D-dimer test which is currently used as a marker to decide on whether to continue therapy is associated with a 4% fatality rate. Both Xarelto and Pradaxa have demonstrated non-inferiority over warfarin in PhIII trials – EINSTEIN-DVT and RECOVER study respectively. Although the two trials are not comparable, but taking a clue from total evidence available in the VTE prevention/treatment trials, Xarelto obviously appears to be best poised as the new mainstay treatment for DVT. A number of studies (RECOVER 2 – Pradaxa, AMPLIFY- Eliquis and EINSTEIN-PE – Xarelto and HOKUSAI- Edoxaban) are ongoing in DVT/PE treatment.
This therapy class report analyses the practical issues in the adoption of new generation anticoagulants, major upcoming milestones, clinical trial design/data and cost-effectiveness of recently launched and upcoming molecules. This report will provide insightful information about the performance of molecules in oral anticoagulation arena in all the indications (SPAF, VTE, ACS) and the way these newer drugs will be positioned to garner the benefits against Aspirin/Warfarin/Lovenox are discussed.
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