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AstraZeneca’s heart drug impresses, but bleeding risks a concern

Firm still hopes the new Brilinta data can help the medicine be a blockbuster


AstraZeneca has released positive data for its heart drug Brilinta that it hopes will help turn the treatment's fortunes around.

The data, formed from the 21,000-patient Pegasus clinical trial, saw Brilinta (ticagrelor) plus low-dose aspirin, compared to placebo plus low-dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients, who had experienced a heart attack one to three years prior to study enrolment.

The study showed that it could cut heart risks significantly in the patient population, but this came at the price of increasing the risk of bleeding.

The firm has said before that it believes the antiplatelet drug can make around $3.5bn a year by 2023, and help shore up the losses from recent generic competition across its portfolio. 

But in order to do this, Brilinta will need to gain new licences, and be able to show that it can help bring care to a broader group of heart patients. The latest Pegasus trial can go some way to do this, but analysts were lukewarm in their reception to the data.

Citigroup analyst Andrew Baum said in a note to clients that the results were “good but not great” while Seamus Fernandez of Leerink was more downbeat, saying the outcome was “far from an epiphany” for cardiology medicine.

Analyst forecasts currently suggest Brilinta sales of $1.5bn by 2020. The drug made just $476m in 2014 despite being on the market for four years.

The drug encountered several setbacks on its way to approval and in 2010 the FDA delayed its review of the drug twice. 

Last year, Brilinta also failed to show any significant difference between pre-hospital and in-hospital administration in terms of pre-PCI procedural effectiveness - a technique currently used in the treatment of heart disease.

The current standard care for patients more than one year on from a heart attack is aspirin alone to prevent clotting, but AstraZeneca wanted to prove the case for dual therapy by adding Brilinta to the mix.

Elisabeth Björk, VP and head of cardiovascular and metabolic diseases, global medicines development at AstraZeneca, said: “As a company we are committed to furthering cardiovascular research and are proud to have delivered the Pegasus-Timi 54 study, AstraZeneca's largest clinical trial, involving more than 21,000 patients worldwide. 

“Building on the landmark Plato trial in acute coronary syndrome, the positive Pegasus study adds to the body of evidence for Brilinta and is the first prospective trial to evaluate longer term dual antiplatelet therapy in higher risk patients with a history of a heart attack.

“We have just submitted regulatory filings to the European Medicines Agency and the US FDA and we look forward to working with these agencies towards a potential new indication in major markets.”

Article by
Ben Adams

17th March 2015

From: Research



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