PARADIGMS

Oral treatment with Gilenya (fingolimod) is more effective than Avonex (interferon beta-1a) for controlling brain lesion activity and brain volume loss in children with pediatric-onset multiple sclerosis (POMS), two-year results of the PARADIGMS study show. That means Gilenya provides an effective treatment option for…

Gilenya (fingolimod) was approved by the European Commission as a treatment for children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS), Novartis announced. The therapy is already approved in Europe to treat RRMS patients 18 and older. With this newest decision, Gilenya has become…

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended that Gilenya (fingolimod) be approved to treat children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS). If the CHMP opinion is accepted, Gilenya — marketed by…

While the treatment and care of children and teenagers with multiple sclerosis (MS) has seen many developments in recent years, there are still many challenges to overcome, according to a presentation given by Brenda Banwell, MD. Banwell, who is the chief of child neurology at the Children’s Hospital…

Gilenya (fingolimod) has become the first disease-modifying therapy approved by the U.S. Food and Drug Administration (FDA) to treat children and adolescents with relapsing forms of multiple sclerosis (MS). This expanded approval allows Gilenya, previously indicated for adults patients 18 or older, to be used to treat pediatric relapsing MS…

An additional analysis of data collected during the Phase 3 PARADIGMS trial found Gilenya (fingolimod) can prevent the progression of disability and control multiple sclerosis (MS) activity in pediatric patients. Results of the analysis were the subject of an oral presentation Tuesday at the 2018 American Academy of Neurology…

Gilenya (fingolimod) lowered relapse rates in children and adolescents with relapsing multiple sclerosis at a “magnitude” — almost 82 percent — never before seen in a scientific study and could be “life changing” for these hard-to-treat patients, a top researcher with Novartis, the treatment’s developer, said in an…

Gilenya (fingolimod) was seen to significantly reduce relapses in children and teenagers with multiple sclerosis (MS), according to data from a Phase 3 study — the first successfully conducted in pediatric patients. Novartis, the therapy’s developer, is preparing to file requests for Gilenya to be approved to…

Gilenya decreased relapses in children and adolescents with multiple sclerosis in the phase 3 PARADIGMS trial, according to the therapy's developer, Novartis. The Swiss company will present the trial's results at the 7th Joint ECTRIMS-ACTRIMS meeting, set for Oct. 25-28 in Paris. The study addressed the safety and efficacy of an oral, once-daily dose of Gilenya in 215 MS patients aged 10 to 17. Participants received 0.5 mg or 0.25 mg of Gilenya, according to their body weight, and results were compared with those of intramuscular Avonex (interferon beta-1a given once weekly). The trial — conducted at 87 sites in 25 countries — was designed in partnership with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Pediatric Multiple Sclerosis Study Group. Gilenya led to a "clinically meaningful decrease in the number of relapses" over a period of up to two years, compared to Avonex, according to the trial. The safety results of Gilenya matched those observed in previous trials, with adverse events more likely among the Avonex group. Importantly, the PARADIGMS trial is the first-ever randomized, controlled Phase 3 study of a disease-modifying therapy in pediatric MS. No treatment is currently available for children and adolescents with MS. Novartis will now complete a thorough evaluation of the results and later submit Gilenya for approval by regulatory agencies. It will also extend the study to a five-year period.