Novartis takes Leqvio in-house to get submission back on track

When the US regulator said in December it could not complete its review of a submission for heart med inclisiran, a potential blockbuster, it came as something of a shock.

Now developer Novartis (NOVN: VX), a Swiss pharma giant, is cutting contractor Corden Pharma out of the loop in a bid to get the show back on the road.

The US Food and Drug Administration’s Complete Response Letter (CRL) indicated that unresolved questions related to Corden’s manufacturing site in Italy would prevent the target date of December 23 being met.