Novartis' Siponimod Heads Towards Regulators As Experts Question Its Effects

As Novartis prepares its imminent US filing for its Gilenya follow-up siponimod some experts are underwhelmed by its pivotal EXPAND study.

Multiple Sclerosis — • Source: Shutterstock

Data from Novartis AG's pivotal EXPAND study of its Gilenya follow-up siponimod (BAF312), which suggest it could be the first potential therapy to meaningfully delay disability progression in typical secondary progressive multiple sclerosis (SPMS) patients, have been published in The Lancet but experts in an accompanying commentary have questioned the extent of its efficacy.

The data from EXPAND were first presented at the September 2016 ECTRIMS meeting and showed that siponimod reduced the risk of disability progression with a safety profile similar to that...

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