Wednesday, February 21, 2018

Gilenya of Novartis

Novartis’s (NVS) Gilenya reported sales of $825 .0 million in 4Q17, which is a year-over-year (or YoY) drop of 1.0% on a constant currency basis. On April 12, 2017, the United States Court of Appeals for the Federal Circuit ruled against Novartis.

The court declared that Gilenya’s formulation patent protecting the drug until 2026 is invalid. So, Gilenya is protected from generic erosion in the relapsing-remitting multiple sclerosis (or RRMS) indication until 2019.
Novartis has submitted applications to regulatory bodies in the US and the European Union (or EU) seeking approval for Gilenya in pediatric multiple sclerosis (or MS) indication.

In the first completed Phase 3 trial, PARADIGMS, in thepediatric MS patient population, Gilenya demonstrated an 82.0% drop in the relapse rate compared to interferon β-1a. Additionally, Gilenya scored better on parameters such as MRI lesions, brain shrinkage rate, and safety profile.



Post a Comment

<< Home