September 2010 -- Gilenya is set to become the leading treatment in 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 multiple sclerosis (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.
“Datamonitor expects widespread use as a first-line therapy, given the high efficacy, convenience and less invasive 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.
“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.”
** From the report Multiple Sclerosis | Next generation therapies signal start of new era Trung Huynh is available for comment. To arrange an interview or for further details regarding this release please contact Joe Dixonin the Datamonitor press office on + 44 (0)161 238 4083, or email jdixon@datamonitor.com
ABOUT DATAMONITOR
The Datamonitor Group (www.datamonitor.com) is a world-leading provider of premium global business information, delivering independent data, analysis and opinion across the Automotive, Consumer Markets, Energy & Utilities, Financial Services, Logistics & Express, Pharmaceutical & Healthcare, Retail, Sourcing, Technology and Telecoms industries. Combining our industry knowledge and experience, we assist more than 6,000 of the world’s leading companies in making better strategic and operational decisions.
