CMHP recommends against serelaxin for heart failure use
- CMHP has recommended against approval of Novartis's seralaxin, citing insufficient phase III data.
- Novartis plans to resubmit with data from a larger phase III trial.
- FDA rejected seralaxin earlier this month.
Seralaxin, developed by Novartis as a breakthrough therapy for heart failure, was rejected by the FDA in mid-May because the agency felt there was not enough efficacy data to approve it. More recently, CMHP recommended against EMA approval of Seralaxin for similar reasons.
Novartis plans to re-apply with data from a 6,300-person trial, but the data will not be reported for a couple of years.
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