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AstraZeneca's Zurampic FDA Approved with Boxed Warning

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AstraZeneca plc 's AZN Zurampic (lesinurad; 200 mg) gained FDA approval in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia (high levels of uric acid in the blood) associated with gout in patients who have not achieved target serum uric acid (sUA) levels with an XOI alone. Approval came a week ahead of schedule.

We remind investors that the FDA was expected to render a final decision on Zurampic by Dec 29, 2015. FDA approval was largely expected as the Arthritis Advisory Committee had issued a favorable opinion in Oct 2015.

However, Zurampic's approval in the U.S. comes with a boxed warning regarding the risk of acute kidney (renal) failure, which is more common when used without an XOI and with higher-than-approved doses of Zurampic. Moreover, the company will be required to conduct a post-marketing study to further evaluate the renal and cardiovascular safety of Zurampic.

We are encouraged by the FDA approval of Zurampic. Per information provided by AstraZeneca in its press release, gout is a serious and debilitating form of inflammatory arthritis affecting more than 15.8 million people in major markets including the U.S., France, Germany, Italy, Spain, the UK and Japan.

We note that Zurampic (200 mg) is currently under review in the EU. Late last week, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion in favor of approving the drug in combination with an XOI for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target sUA levels with an adequate dose of an XOI alone.

A decision regarding EU approval should be out in the first quarter of 2016. With the CHMP in favor of approving Zurampic, we believe chances of gaining EU approval are high.

Zurampic became a part of AstraZeneca's gout portfolio through its acquisition of Ardea Biosciences in 2012. The acquisition also added another gout candidate, RDEA3170, to the company's portfolio.

AstraZeneca is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN , Mylan N.V. MYL and Anika Therapeutics Inc. ANIK . All three carry a Zacks Rank #1 (Strong Buy).

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ASTRAZENECA PLC (AZN): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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