Novartis to submit more on heart failure drug after EU setback
ZURICH (Reuters) - Novartis said it would ask the European health regulator to look at its heart failure drug serelaxin again after the body took an unfavorable position on it Friday.
"Novartis announced today it will shortly submit a revised filing package, including new data analyses, for re-examination for conditional approval of RLX030, or serelaxin," the Basel-based drugmaker said in a statement.
Novartis, which had originally hoped to win approval for serelaxin this year, said a revised opinion could be granted in the second quarter.
(Reporting By Katharina Bart)
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