Novartis gains edge in MS treatment race
pharmafile | February 22, 2010 | News story | Research and Development, Sales and Marketing | Cladribine, Gilenia, MS, Novartis
Novartis’ new oral multiple sclerosis treatment Gilenia will be given a priority review by the FDA.
This could lead to a US approval for the drug within six months, although as a new molecular entity the FDA may require an Advisory Committee meeting that extend its review of Gilenia (fingolimod) beyond June 2010.
Global head of development at Novartis Trevor Mundel said: “We welcome the decision granting priority review to Gilenia, which underscores the potential benefits of this medicine to patients
“MS is a leading cause of neurological disability in young adults, particularly in women, and this medicine has the potential to offer real advances in the care of people with MS.
Trials for Novartis’ Gilenia include more than 4,000 patient years of clinical trial data. The FREEDOMS study shows Gilenia reduced relapse rates by 54-60% compared to placebo, and disability progression by 30-32%.
The phase III TRANSFORMS one-year study showed that Gilenia reduced relapses significantly more than the current treatment involving interferon beta-1a.
Gilenia’s main competition to be the first oral treatment for MS is Merck Serono’s cladribine, which received a ‘refuse to file’ notice in November 2009.
Despite the setback, Merck Serono says it is talking to the FDA about re-submitting its application in the immediate future.
The biggest selling MS treatments currently are Biogen’s Avonex and Merck Serono’s Rebif, both injectable forms of interferon beta 1a.
Data from Merck Serono’s CLARITY trial for cladribine, presented in April 2009, showed that the primary endpoint and key secondary endpoints of the CLARITY trial were met. 1,326 patients took part in a two-year randomised, double-blind, placebo-controlled, international trial.
An estimated two million worldwide suffer from multiple sclerosis (MS), most commonly from the relapsing forms of the chronic, inflammatory condition of the central nervous system.
The main target of MS drug treatment is the cessation of relapses and the progression of disability.
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