Results from a phase III trial conducted by Novartis AG (ADR) (NYSE:NVS) has shown that its Gilenya treatment aimed at multiple sclerosis reduces symptoms of the disease besides slowing progression. The primary endpoint of the phase III PARADIGMS trial was reached and it showed a substantial decline in relapses in those pediatric patients treated with fingolimod or Gilenya compared to those who were put on Avonex, a treatment developed by Biogen Inc (NASDAQ:BIIB).
“The outcome of this study is very exciting news for the MS patient community, all of whom benefit from potential advances in high-quality, evidence-based care such as this,” said the chief medical officer and drug development head of Novartis, Vas Narasimhan.
This is the first controlled and randomized phase III study of a disease-modifying treatment in pediatric multiple sclerosis and it will assist Novartis in expanding its franchise. In the trial children and adolescents aged between 10 and 17 years numbering 215 were enrolled. Depending on the body weight of the participant, one random group of patients was given intramuscular interferon beta-1a once a week or 05 or 0.25 mg of fingolimod once per day.
The primary endpoint of the study was the annualized relapse rate after 24 months of treatment. Secondary endpoints included pharmacokinetic and safety properties, Gadolinium enhancing T1 lesions and the quantity of newly enlarged or new T2 lesions.
The first symptoms of most patients suffering from multiple sclerosis begin to show when they are aged between 20 and 40. But in between 2% and 5% of the patient population the disease can display symptoms before the age of 18. Just like many other newer multiple sclerosis treatments Gilenya has not received approval for use in pediatric patients and the data from the trial will have to be examined by health authorities and a thorough analysis conducted.
Currently Gilenya is among the top sellers in the drugs portfolio of Novartis and is this year expected to exceed $3 billion in sales. The field is however fiercely competitive and one of the latest entrants into the segment is Ocrevus which was developed by Roche.
On Wednesday shares of Novartis AG rose by 0.07% to close the day at $83.86.