EC approves marketing authorisation update to AstraZeneca's 'Forxiga'
AstraZeneca announced that the European Commission has approved an update to the marketing authorisation for ‘Forxiga’ (dapagliflozin) to include positive cardiovascular outcomes and renal data from the phase 3 ‘DECLARE-TIMI 58’ trial in adults with type-2 diabetes (T2D) on Monday.
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The FTSE 100 pharmaceutical giant said the trial enrolled a majority of patients with no existing cardiovascular disease.
It explained that in the phase 3 DECLARE-TIMI 58 trial, Forxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or CV death versus placebo, one of the two primary efficacy endpoints.
There were said to be fewer major adverse cardiovascular events observed with Forxiga for the other primary efficacy endpoint too, however that did not reach statistical significance.
The phase 3 DECLARE-TIMI 58 trial confirmed the well-established safety profile of Forxiga, AstraZeneca claimed.
It said the trial showed no significant imbalance with Forxiga versus placebo in amputations, fractures, bladder cancer or Fournier's gangrene.
Inclusion of the DECLARE-TIMI 58 trial data to the medicine's label was currently under regulatory review in the US and China.
“For patients with type-2 diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke,” said Mene Pangalos,the company’s executive vice-president of biopharmaceuticals research and development.
“In the phase 3 DECLARE-TIMI 58 trial, Forxiga reduced the composite endpoint of hospitalisation for heart failure or cardiovascular death in patients with type-2 diabetes, and we look forward to bringing these additional benefits of the medicine to people with type-2 diabetes in the EU.”