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Multi-blockbuster sales expected as Gilenya changes Multiple Sclerosis landscape

28 Sep 2010, by Informa Insights

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Melbourne, 23rd September 2010 – Gilenya is set to become the leading treatment in multiple sclerosis (MS) with multi-blockbuster sales, ending the decade long dominance of interferon betas and Copaxone (glatiramer acetate, Teva) says Trung Huynh, healthcare analyst at Datamonitor.

“The FDA approved Novartis’s Gilenya (formally Gilenia; fingolimod) yesterday. It is the first of a new generation of MS disease modifying therapies addressing key unmet needs of oral administration and increased efficacy.”

“In July 2010, Gilenya lost out in the race to become the world’s first oral disease-modifying after Merck Serono’s Movectro (oral cladribine) won Russian approval. However, supported by robust clinical trial data, the once daily pill will enter the lucrative US market as the first oral therapy to treat relapse remitting MS, offering patients a highly welcomed alternative to injections.”

“Gilenya acts by reducing lymphocytes available to mount an autoimmune reaction to the myelin sheath.” Trung Huynh, healthcare analyst at Datamonitor, comments: “Despite safety concerns over Gilenya’s mechanism of action, strong FDA advisory panel backing as a first-line therapy has allayed these fears”. Novartis will conduct post-approval studies at a lower dose than the proposed 0.5mg and also long-term safety studies for people susceptible to the drug’s known side-effects.”

“Datamonitor expects widespread use as a first-line therapy, given the high efficacy, convenience and less invasive nature of administration, and forecast Gilenya to capture seven major market sales of $2.4 billion in 2019. With the forthcoming arrivals of more oral and efficacious therapies driving market growth these are exciting times ahead for the development and treatment of MS.”

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