The market for AstraZeneca’s (LON:AZN) potential ‘blockbuster’ drug has been expanded with a new approval by the US Food and Drugs Administration (FDA).
The branded drug Brilinta (which is also known as ticagrelor) is a blood thinner, and it has until now been prescribed to patients for up to one year following a heart attack, but, the new approval means it can be taken for longer.
Patients with a history of heart attack can now be given the drug beyond twelve months, AstraZeneca told investors.
“We know that patients remain at risk beyond the first year after their heart attack,” said Elisabeth Björk, AstraZeneca’s head of cardiovascular and metabolic diseases and global medicines development.
“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."
The expanded indication by the FDA was granted via priority review, and it follows a study which showed significantly reduced risks of patients dying from cardiovascular causes, having another heart attack, or having a stroke.
Marc Sabatine, lead investigator for the study, in the AstraZeneca statement said: “While it's important that physicians tailor their treatment approach for each patient, these data speak to the clinically important benefit that can be gained when adding ticagrelor to the current standard therapy in a patient population at increased risk for recurrent cardiovascular events in the long-term."
Following the FDA approval new 60mg Brilinta tablets, to be taken twice daily, will be made available in pharmacies by the end of September, AZN said.
The drug has been approved in 100 different countries.