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Novartis Multiple Sclerosis Drug Gets FDA Nod for Adolescents


Novartis AG 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 industry’s 3.4% decline.

Apart from Gilenya, Novartis' MS portfolio includes Extavia (interferon beta-1b for subcutaneous injection) which is approved for the treatment of relapsing forms of MS. The company also other pipeline candidates like BAF312 (siponimod) and OMB157 (ofatumumab), under investigation in relapsing MS. Novartis’ generic division, Sandoz, markets Glatopa (a generic version of Teva Pharmaceutical’s TEVA Copaxone (both 20 and 40 mg).

We note that Biogen, Inc. BIIB holds a strong position in the MS market with a wide range of products including Avonex, Tysabri, Tecfidera and Plegridy.

Zacks Rank & Stock to Consider

Novartis currently carries a Zacks Rank #3 (Hold).

A better-ranked stock from the same space is Ligand Pharmaceuticals LGND, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates moved up from $4.07 to $4.09 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with an average beat of 31.79%. The company’s shares have rallied 30.1% year to date.

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