At a glance: Bad news for Astra-Zeneca’s Exanta

AstraZeneca’s oral anticoagulant drug – what’s the story? The US Food and Drug Administration (FDA) last week refused approval for Exanta in any form. The company put forward three indications for the drug, including its use to treat blood clots after knee surgery.

So much for the US. What’s the position in this country on Exanta?

It’s not yet in use in the UK, but discussions with regulatory authorities are ‘ongoing’, according to AZ. Exanta has already been launched in seven European countries this year, including Germany, Sweden and Norway, after receiving approval from European Union regulatory bodies for use in elective knee and hip replacements.

So which UK PR agencies have got some midnight oil to burn, then?

Cohn & Wolfe – whose healthcare arm was appointed seven months ago to work on Exanta worldwide – and Chandler Chicco Agency, which has held the UK account since 2002, say it’s ‘business as usual’.

Well, what comms strategy is AZ going to adopt?

On appointment, C&W’s strategic PR plan included the communication of trial results and education of specialists through trade press. But AZ is now tight-lipped over how the company will approach this setback in PR terms. A spokeswoman tells us: ‘We wouldn’t wish to comment on what actions or plans are in place.’ AZ chief executive Sir Tom McKillop has said regulators are being timid.

Might need more than that. Anything else AZ will be looking at?

Investor relations activity is a good bet, since the company has come under fire in the City since the FDA announcement. And the company is targeting emerging pharma markets, with a focus on Mexico and China.

What was the problem with Exanta?

Worries about safety and effectiveness, in a nutshell. Exanta has been associated with liver problems in patients.

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