AstraZeneca’s resurgent antiplatelet drug Brilinta has scored another FDA approval, getting the go-ahead for longer-term use in heart attack patients.
The FDA priority review approval covers use of the drug beyond the first year in patients who have suffered a prior myocardial infarction (MI) and has been granted on the back of the 21,000-patient PEGASUS study.
The trial showed Brilinta plus low-dose aspirin was significantly more effective than placebo plus aspirin at reducing the risk of dying from cardiovascular causes, having another heart attack, or having a stroke.
AZ’s head of cardiovascular and metabolic disease drug development, Elisabeth Björk, said it is well known that patients remain at risk beyond the first year after their heart attack, adding: “Today’s approval is an important milestone that underscores the role BRILINTA can play in reducing the risk of a subsequent cardiovascular event for patients both in the acute setting and in the longer term.”
Brilinta was previously approved as 90mg tablet given twice-daily after being shown to be superior to clopidogrel in the PLATO trial, and the new indication gives a green light to a lower 60mg tablet for use as a maintenance dose. The company indicated it would launch the new formulation before the end of the month.
The development is a boost for AZ as it expands the market for Brilinta (ticagrelor) and makes it more likely to meet the company’s bullish predictions of $3.5bn in annual sales by 2023, made by chief executive Pascal Soriot while AZ was fending off a takeover attempt from Pfizer.
The drug still has a long way to go but grew 42% in the first of the year, bringing in $275m and setting it on course for around $600m for 2015 as a whole, although some analysts have expressed scepticism that it can top $2bn at peak.
The maintenance indication is central to AZ’s sales predictions for Brilinta as the company believes it could double the number of patients taking the drug. However, it has been suggested the PEGASUS data could also lead to increased prescribing of much cheaper generic clopidogrel, eating into its capacity for expansion.