AstraZeneca Fulfills Approval Commitment To Make 5mg Dose Of Crestor Available In EU

Main Category: Cholesterol
Article Date: 24 Apr 2005 - 0:00 PDT

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AstraZeneca announced today that agreement has been reached under the EU arbitration procedure on label wording for a 5mg dose of CRESTOR, the cholesterol lowering treatment, paving the way for its availability across the European Union The commitment to make the 5mg dose available was made when CRESTOR 10-40mg was first approved in Europe in 2003. Approval of the original dose range of 10-40mg was based, in part, on clinical trial data showing that more than 80 per cent of patients reach their LDL-cholesterol target on the 10mg dose.

AstraZeneca has worked closely with European regulators to reach agreement following the referral of the mutual recognition procedure (MRP) to arbitration at the end of 2004, bringing the European label closer to that recently agreed with US regulators, and giving doctors added flexibility in treating patients. The agreed label focuses on the appropriate patient population for whom a 5mg start dose might be recommended. The choice of start dose should be based on an individualised assessment of cardiovascular risk, versus the potential for side effects. In addition, the label specifies the 5mg start dose is to be used for Asian patients and patients with predisposing factors for myopathy.

In comparative studies CRESTOR 5mg is more effective than the usual start dose of atorvastatin (10mg) at reducing LDL-C (-42 per cent vs. -36 per cent). However, AstraZeneca believes that many patients will still require CRESTOR 10mg to reach their cholesterol goal.

The superior efficacy of CRESTOR has been established across a broad range of clinical trials, and the benefit:risk for CRESTOR is now well-established through these trials, as well as post-marketing experience involving over 4.5 million patients and 20 million prescriptions worldwide to date.

Further enquiries to:

Media Enquiries:
Steve Brown, +44 207 304 5033
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------- The recommended start dose is 5mg or 10mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions.

------- The following patients are recommended to start with the 5mg dose:
-- Asian patients
-- patients with predisposing factors for myopathy, eg patients taking concomitant fibrates; patients with moderate renal impairment and elderly patients (aged over 70)

------- A dose adjustment to the next dose level can be made after four weeks, if necessary.

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