Novartis today announced that the European Commission (EC) has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS).
The European market authorization makes Gilenya the first and only oral disease-modifying treatment for children and adolescents based on clinical Phase III data. This young population living with MS have a critical need for an effective treatment option, as they experience two-to-three times as many relapses as adults, often leading to a more severe prognosis and earlier irreversible disability compared to adult-onset MS[2].
‘We are excited by the news that there is now a new approved treatment indicated for young people with RRMS in Europe – hopefully this will be the first step to having more therapy options for children and adolescents with MS,’ said Pedro Carrascal, President, European Multiple Sclerosis Platform. ‘Young patients affected by MS often experience a more severe impact during their overall lifetime. Today’s approval provides an opportunity for a brighter future for them and their families.’
‘Early onset MS can have a devastating impact on children and adolescents’ daily life, such as going to school and spending time with friends and family,’ said Paul Hudson, Chief Executive Officer, Novartis Pharmaceuticals. ‘Our mission is to change the course of MS as we’ve been doing since the treatment’s initial approval in 2011, and we won’t stop until we stop MS. We are delighted that today’s decision has brought us one step closer to reimagining the treatment of MS, across all ages.’
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