Correvio Pharma heart drug Brinavess fails to get USFDA nod

In the so-called complete response letter, the USFDA stated that while the submitted data provide substantial evidence of the drug's effectiveness, the data does not provide reassuring evidence of Brinavess' safety, Correvio said.

New Delhi: The U.S. Food and Drug Administration has declined to approve Correvio Pharma Corp's drug to correct irregular rhythm in the upper chambers of the heart, the company said on Tuesday.

In the so-called complete response letter, the FDA stated that while the submitted data provide substantial evidence of the drug's effectiveness, the data does not provide reassuring evidence of Brinavess' safety, the company said.

Read Also: SETBACK: Correvio Pharma heart drug Brinavess fails to win USFDA panel backing

A panel of independent experts to the FDA voted 11-2 against approving the drug, Brinavess, citing serious safety risks, including low blood pressure and irregular rhythm in the lower heart chambers during the trials, earlier this month.

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