Novartis Multiple Sclerosis Drug Gets FDA Nod For Adolescents
Zacks Investment Research | May 13, 2018 09:54PM ET
Novartis AG (NYSE:NVS) announced that the FDA has approved the label expansion for its multiple sclerosis (“MS”) drug Gilenya (fingolimod). The drug has been approved for the treatment of children and adolescents aged between 10 and 18 with relapsing forms of multiple sclerosis (“RMS”). The drug is the first disease-modifying therapy indicated for individuals aged between 10 and 18.
We note that Gilenya is already approved in the United States for the first-line treatment of RMSin adults and in Europe for adult patients with highly-active relapsing-remitting MS (“RRMS”).
The approval of Gilenya in patients aged between 10 and 18 was supported by data from the phase III PARADIGMS study. The study met its primary endpoint and showed that oral Gilenya resulted in a significant and clinically meaningful reduction in the number of relapses (annualized relapse rate) by about 82%in children/adolescentsover a period of up to two years, compared to interferon beta-1a intramuscular injections
Novartis stock has lost 7.6% year to date compared with the Original post
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