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AstraZeneca wins EU approvals for Zurampic and Brilique

Its gout drug receives a licence and antiplatelet therapy gains a new indication

AstraZenecaAstraZeneca has received European approvals for its first-in-class gout drug Zurampic and oral antiplatelet treatment Brilique.

The European Commission approved Zurampic (lesinurad), for use in combination with a xanthine oxidase inhibitor (XOI), such as generic allopurinol or Takeda's Uloric (febuxostat).

The drug is a selective uric acid reabsorption inhibitor (SURI) that increases uric acid excretion and so lowers serum uric acid (sUA) levels in patients for whom a dose of XOI is not sufficient.

Data from 1,537 participants in three phase III trials - CLEAR1, CLEAR2 and CRYSTAL - represents the largest set of clinical trial data for gout patients treated with a combination urate lowering therapy to date and formed the basis of the EU approval.

The decision adds to its position in the US, where Zurampic was approved by the FDA in December 2015.

A condition of the EU approval will see AstraZeneca conduct a safety profile study - Non-Interventional Post-Authorisation Safety Study (PASS) - of patients with a history of cardiovascular disorder who have been exposed to Zurampic as well as a safety and efficacy renal study in patients with creatinine clearance of 30-45L/min.

Brilique expands its indications
The European Commission has also approved AstraZeneca's Brilique (ticagrelor) for use by patients who have suffered a heart attack at least one year prior and are at risk of developing a further atherothrombotic event.

Approval of the new indication was based on the PEGASUS TIMI-54 outcomes trial that involved more than 21,000 patients and showed Brilique significantly reduced the primary endpoint of cardiovascular death, heart attack or stroke compared to placebo.

Sean Bohen, AstraZeneca's chief medical officer and executive vice president for global medicines development, called the approval an “important step” in meeting high-risk patients' needs.

He added: “A growing body of evidence continues to show that the risk of experiencing a subsequent cardiovascular event continues beyond the first year after a patient has a heart attack.

“We are committed to finding new treatment solutions for these patients who remain at risk.”

A 90mg dose of Brilique is already available in the EU for adults with acute coronary syndrome (ACS), but the approval of a 60mg dose means that patients with a history of heart attack can continue daily treatment with Brilique after the first year.

The lower dosage was approved in the US in September last year and is now applicable to all 28 EU member states as well as Iceland, Liechtenstein and Norway.

Article by
Rebecca Clifford

22nd February 2016

From: Regulatory



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