IRISH DRUG development company Amarin has agreed with the US Food and Drug Administration the design of a test to assess whether its cardiovascular drug candidate can reduce the risk of heart attacks.
The firm says the special protocol assessment for the six-year study is the final hurdle before it seeks FDA approval for its drug, which has been shown in two phase III trials to lower very high triglycerides – blood fats – without raising levels of “bad” LDL cholesterol or producing adverse side-effects. The company intends to file a new drug application for the treatment – a purified Omega-3 fish oil AMR101 – by next month.
The “outcomes” test is expected to continue following any approval of the drug. It will feature 8,000 patients worldwide – half of whom are expected to be enrolled by the end of next year – and is expected to cost about €100 million.
The company is hopeful the Reduce-IT study will provide new opportunities for the drug following the success of a much smaller outcomes study for the drug in Japan.
The firm also reported second-quarter figures showing cash reserves of $131.4 million.
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