AstraZeneca heart drug given US approval

Anglo-Swedish pharmaceuticals firm AstraZeneca announced on Thursday that the US Food and Drug Administration (FDA) has approved its Brilinta heart drug for use on patients in the United States.

AstraZeneca heart drug given US approval

The Food and Drug Administration (FDA) backed the use of Brilinta tablets to reduce the risk of heart attacks, strokes and death, AstraZeneca said in a statement.

“The FDA approval of Brilinta is good news for patients in the United States and represents a significant milestone as we seek to help ensure… patients around the world have access to this innovative medicine,” AstraZeneca chief executive David Brennan said in the statement.

AstraZeneca is hoping that the drug, which won EU approval in late 2010, can rival current blockbuster heart drug Plavix that is produced by pharmaceutical giant Sanofi-Aventis and BMS.

“With over one million people affected by ACS (acute coronary syndrome) in the US each year, the fact that physicians have a new and more effective treatment option than clopidogrel to help reduce the rate of heart attack and cardiovascular death in these patients is an important advance,” Brenna said.

According to the American Heart Association, over one million Americans are hospitalised with ACS every year.

Brilinta is now approved in 39 countries including the US, Brazil, Australia and Canada and in the EU it is marketed under the trade name Brilique.

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Norway to send 200,000 AstraZeneca doses to Sweden and Iceland

Norway, which has suspended the use of AstraZeneca's Covid vaccine until further notice, will send 216,000 doses to Sweden and Iceland at their request, the Norwegian health ministry said Thursday.

Norway to send 200,000 AstraZeneca doses to Sweden and Iceland
Empty vials of the AstraZeneca vaccine. (Photo by GABRIEL BOUYS / AFP)

“I’m happy that the vaccines we have in stock can be put to use even if the AstraZeneca vaccine has been paused in Norway,” Health Minister Bent Høie said in a statement.

The 216,000 doses, which are currently stored in Norwegian fridges, have to be used before their expiry dates in June and July.

Sweden will receive 200,000 shots and Iceland 16,000 under the expectation they will return the favour at some point. 

“If we do resume the use of the AstraZeneca vaccine, we will get the doses back as soon as we ask,” Høie said.

Like neighbouring Denmark, Norway suspended the use of the AstraZeneca jab on March 11 in order to examine rare but potentially severe side effects, including blood clots.

Among the 134,000 AstraZeneca shots administered in Norway before the suspension, five cases of severe thrombosis, including three fatal ones, had been registered among relatively young people in otherwise good health. One other person died of a brain haemorrhage.

On April 15, Norway’s government ignored a recommendation from the Institute of Public Health to drop the AstraZeneca jab for good, saying it wanted more time to decide.

READ MORE: Norway delays final decision on withdrawal of AstraZeneca vaccine 

The government has therefore set up a committee of Norwegian and international experts tasked with studying all of the risks linked to the AstraZeneca and Johnson & Johnson vaccines, which is also suspected of causing blood clots.

Both are both based on adenovirus vector technology. Denmark is the only European country to have dropped the AstraZeneca
vaccine from its vaccination campaign, and said on Tuesday it would “lend” 55,000 doses to the neighbouring German state of Schleswig-Holstein.