The decision is a blow to Novartis, which believes that Serelaxin is a potential blockbuster that could help it overcome the effect of patent expirations.
Novartis intends to ask the panel to reconsider its view; if it did so, the the Swiss company could start selling the drug in Europe even though a Phase III trial is still continuing. In the U.S., Serelaxin has been designated as a "breakthrough therapy." (PR)
Meanwhile, the panel has provided a positive opinion of Novartis' Xolair treatment for the skin disease chronic spontaneous urticaria.