18th Mar 2019 14:27
LONDON (Alliance News) - AstraZeneca PLC on Monday said the first sub-analyses from its phase three trial of Farxiga found it reduced the relative risk of major adverse cardiovascular events in diabetics who had previously suffered a heart attack.
In a pre-specified sub-analysis of Astra's phase three Declare-Timi 58 trial, Farxiga reduced the relative risk of a major event by 16% versus placebo in patients with type-2 diabetes who have already had a heart attack.
Not only that, but in another pre-specified sub-analysis the drug reduced the relative risk of hospitalisation for heart failure in type-2 diabetics.
A pre-specified analysis is one that is planned and documented before the data is examined, which makes it less susceptible to bias than a post-hoc sub-analysis.
Earlier on Monday, Astra also announced that its drug Saracatinib, which treats a type of chronic and fatal lung disease called idiopathic pulmonary fibrosis, has been granted orphan drug status in the US.
Orphan drug status is granted in the US by the Food & Drug Administration and is for medicines intended to treat disorders affecting fewer than 200,000 people. This designation is intended to streamline the approvals process for these types of drugs and grants a longer period of market exclusivity in order to incentivise the development of drugs for rare diseases.
Shares in AstraZeneca were up 1.3% at 6,358.00 pence on Monday.
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