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news.Serono has submitted applications to both US and European regulators seeking marketing approval for a new more tolerable formulation of its multiple sclerosis drug, Rebif.
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Data from a phase III clinical trial in patients with relapsing forms of MS show that the new formulation of Rebif results in a substantial improvement in overall tolerability, as measured by pre-specified parameters including injection site reactions, which are an important factor for patients when choosing an MS therapy.
The trial data also show that the incidence of antibody formation with the new formulation of Rebif is reduced.
“These results are promising news for patients with multiple sclerosis,” said Professor Per Soelberg Sorensen, from the Danish MS Research Center, Copenhagen University Hospital, Rigshospitalet and an investigator of the trial. “While Rebif is well established in the treatment of relapsing forms of multiple sclerosis, results from this clinical trial show that the new formulation offers promising improvements which could translate into additional benefits to the patient.”