Strengths
The first novel anticoagulant to secure approval for stroke prevention in atrial fibrillation (AF), entering the US market in November 2010
No requirement for anticoagulation monitoring and dose adjustment, and no food effect  
In the RE-LY trial in AF, Pradaxa showed comparable to superior efficacy in stroke prevention, compared with warfarin, with equal to lower bleeding risk
A subgroup analysis from RE-LY showed that Pradaxa 150 mg bid reduced the rate of stroke by 35% compared with well-controlled warfarin, irrespective of a patient's stroke risk  
Comparable to Lovenox in the prevention of major venous thromboembolism (VTE) and VTE-related mortality after both knee and hip replacement, according to RE-NOVATE data  
Equal efficacy to well-controlled warfarin in the treatment of acute VTE, but with a 37% reduction in major or clinically relevant bleeding risk over 6 months, according to RECOVER data

Weaknesses
A superiority claim over warfarin in stroke prevention was rejected for inclusion in the label by the FDA
A 110 mg doseage was not approved for use in patients at higher bleeding risk  
A higher risk of myocardial infarction was seen in RE-LY
Twice daily dosing, compared with once daily for Xarelto  
Not approved in the US for VTE prevention post-surgery, unlike Xarelto which was approved in July 2011
Has faced some safety concerns, and the label was updated to mandate renal testing in high-risk patients
Associated with a 6% rate of major gastrointestinal hemorrhage during each patient year on treatment
Other gastrointestinal side effects, including dyspepsia, nausea and gastritis, are increased compared with warfarin (35% vs 24%)
Current lack of antidote
Very short half-life once removed from specially designed desiccant-containing packaging

Opportunities
Approval in AF opens up a blockbuster market, and Pradaxa could garner a greater share of the market in the near term due to its first mover advantage
Pradaxa could be viewed as superior to Xarelto given Xarelto's lack of superiority to warfarin on an intent-to-treat basis seen in the ROCKET AF trial
Despite the proven efficacy of warfarin in stroke prevention, it has a number of limitations, such as an increased risk of bleeding and the need for patient monitoring and dose adjustment, which has created an unmet need for safe and effective alternatives
Approval in acute coronary syndrome (ACS); phase III trials in this setting began in December 2007
Development of competitor Eliquis in ACS was discontinued following high rates of bleeding in trials
High cost and considerable copay required for Pradaxa may fade as insurers realize potential savings from increased avoidance of ischemic events and hospitalization
AF is the most common sustained cardiac rhythm disturbance, and prevalence increases with age
Up to 60% of cases of AF are caused by hypertension or coronary artery disease, which are increasing in prevalence in most Western societies
ACS is the leading cause of death in the US and one of the most prevalent non-communicable diseases in the world，

Threats
Commercial threat from Eliquis; current phase III data appear to support a superiority claim over warfarin which would differentiate the product
Increased competition in the oral anticoagulant category; the marketing battle between Pradaxa, Xarelto and Eliquis will be key
In Japan, Lixiana is in development for stroke prevention in AF, and could present competition in this market following Pradaxa's launch in March 2011
The drug may not gain approval in ACS given concerns about bleeding
If approved, use in ACS may be limited given the availability of new, more potent antiplatelet regimes, such as AstraZeneca's Brilinta, that improve outcomes with less increased bleeding
Physicians may be reluctant to switch patients who are well controlled on warfarin to other treatment options
Price: the significant price difference between Pradaxa and warfarin could present reimbursement issue
Self administration of low-molecular-weight heparins out of hospital by patients with AF undergoing elective cardioversion is a promising approach that may result in cost savings
Low-molecular-weight heparins, in particular enoxaparin which presents a generic and efficacious option for DVT treatment and prophylaxis following orthopedic surgery

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