6th Nov 2020 08:51
(Alliance News) - AstraZeneca PLC on Friday said its drug Brilinta has now been approved in the US to reduce the risk of stroke.
The approval is for the reduction of stroke risk in patients who have acute ischemic stroke or high-risk transient ischaemic attack and was granted by the US Food & Drug Administration, Cambridge-based Astra noted.
Approval was based on positive results from the FTSE 100-listed drug maker's Thales phase 3 trial, which found that aspirin plus Brilinta 90 milligrams reduced the rate of the composite of stroke and death significantly versus aspirin alone in patients with acute ischaemic stroke or high-risk transient ischaemic attack.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said: "In the US, someone has a stroke every 40 seconds and the impact on a person's life can be truly devastating. Brilinta is a well-established medicine across patients with coronary artery disease and with today's approval, we can now expand its potential to patients with an acute ischaemic stroke or transient ischemic attack."
The drug has now been approved in more than 110 countries to prevent atherothrombotic events in adult patients with acute coronary syndrome as well as in over 70 countries for the secondary prevention of cardiovascular events among patients who are at high-risk and have experienced a heart attack.
The FDA in May approved a new indication for Brilinta to include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.
Shares in Astra were down 2.2% at 8,342.00 pence in London on Friday morning.
On Thursday, the company posted a USD853 million pretax profit for the three months ended September 30, more than twice the USD409 million profit recorded the previous year.
This came as revenue rose 2.7% to USD6.58 billion from USD6.41 billion, while selling, general and administrative costs shrank 15% to USD2.73 billion from USD3.20 billion.
After posting a 4% drop in core earnings per share to USD0.94 for the third quarter and a 13% increase in core EPS for the nine months ended September 30 to USD2.95, Astra maintained its annual core EPS guidance for a mid- to high-teens percentage increase year-on-year.
Core figures are adjusted to exclude certain items such as restructuring charges and provisions, as well as charges and provisions relating to restructuring programmes.
AstraZeneca also maintained guidance for an expected high single-digit to a low double-digit percentage increase in total revenue for 2020.
By Anna Farley; [email protected]
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