Brilinta to be tested for approval

AstraZeneca

AstraZeneca's anti-clotting drug, Brilinta, is set to be scrutinized by an expert panel, who will then inform the Food and Drug Administration (FDA) over whether it should be allowed on the market.

It is make or break for AstraZeneca, who hope to get the drug out for September. It is hoped that Brilinta will be a multi-million dollar medicine for Britain's second biggest pharmaceutical company, which is looking to restock its product line as many of its patents are set to expire over the next few years.

Brilinta might not face the up-hill battle that many have predicted as the advisory committee is expected to analyse data showing that Brilinta demonstrated overall superiority to sanofi-aventis and Bristol-Myers Squibb's $9 billion-a-year blockbuster Plavix in an 18,000-patient study last August that compared the two drugs alongside asprin.

However, among a small number of North American patients on Brilinta plus asprin, there was a non-significant trend towards a worse outcome.

Strong Q2 profits

Despite its success in clinical trials, tough questions during the day-long meeting are expected, as well as looking at the dilemma over whether a pill with clear overall efficacy should be approved in the US, despite failing to show a statistically significant benefit for North American patients.

It is however still expected to pass, proving another boost to AstraZeneca's yearly profits.

AstraZeneca has already had a good year; this week, the company's Q2 results are set to be unveiled and expected to show sales of $8 billion and a pre-tax profit of $2.7 billion, which compares to $7.96 billion in revenue during the same quarter the previous year and $2.6 billion in pre-tax profit.

Brilinta is expected to generate sales of over $1 billion by 2014.

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