Heart drug relief for Astra Zeneca

Good news for staff at Astra Zeneca’s Macclesfield manufacturing plant.

The United States Department of Justice has cleared A-Z over the 18,000-patient clinical trial used to win marketing approval for its important new heart drug Brilinta, following an investigation which had cast a shadow over its prospects.

AstraZeneca views Brilinta as a potential $3.5 billion-a-year seller, but news last October that the DoJ was quizzing the company about the way it conducted the trial raised doubts over its medical value, causing sales growth to stall.

Tom Keith-Roach, vice president for the drug, said: It’s frustrating to think of the patients who probably should have been receiving Brilinta for the last nine months but potentially didn’t because of this cloud hanging over the brand.”

“I think physicians, particularly in the U.S., will now see that a line has been drawn underneath any potential controversy surrounding the trial.”

The Department of Justice move has been considered as highly unusual – as it traditionally focused on potential marketing misconduct by drug makers, rather than looking into the underlying data behind the granting of a license.

AstraZeneca flagged up the promise of Brilinta in its defense against an abortive $118 billion takeover bid by Pfizer Inc earlier this year, although the drug registered only modest sales of $216 million in the first half of 2014.

AstraZeneca have recently reported positive results with an experimental antibiotic called ceftazidime-avibactam as a treatment for hospitalized adult patients with complicated intra-abdominal infections.