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Novartis' Gilenya Approved in EU for Expanded Population
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Novartis AG (NVS - Free Report) announced that the European Commission (EC) has approved a label expansion of multiple sclerosis (MS) drug Gilenya (fingolimod).
The drug is now approved in Europe for the treatment of children who are 10-17 years old with relapsing-remitting forms of multiple sclerosis (RRMS). Following the nod, the drug became the first and only oral disease-modifying treatment for children and adolescents who experience more severe relapses than adults.
The approval was based on positive data from the phase III PARADIGMS study. Data from the study showed that Gilenya significantly reduced the relapse rates by 82% compared to interferon beta-1a. Moreover, 85.7% of patients treated with Gilenya were relapse-free for up to two years compared to interferon beta-1a. Additionally, patients experienced a 77% risk reduction of disability progression when treated with Gilenya versus patients treated with interferon beta-1a.
We note that Gilenya is already approved in the United States and Europe for treating relapsing forms of MS in patients aged 18 years or older. In May 2018, the drug was approved in the United States for the treatment of children aged 10 years or older with MS.
Shares of Novartis have gained 7% year to date compared with the industry’s growth of 7.7%.
We would like to remind investors that, in October 2018, Novartis announced encouraging top-line results from another phase IIIb ASSESS study on Gilenya.
The study evaluated the safety and efficacy of oral, once-daily Gilenya 0.5mg and 0.25mg compared with once-daily subcutaneous injections of Teva Pharmaceuticals’ (TEVA - Free Report) Copaxone (glatiramer acetate) 20mg in patients with RRMS.
The safety of Gilenya across both doses was consistent with the known safety profile of the drug. Notably, more discontinuations due to adverse events and unsatisfactory treatment effects were reported in the Copaxone group. The data from the ASSESS study further reinforces efficacy of Gilenya in treating relapsing MS.
Novartis’ MS portfolio comprises approved drugs like Gilenya and Extavia. Notably, Extavia is approved in the United States for the treatment of relapsing forms of MS. In Europe, the drug is approved to treat people with relapsing-remitting MS and secondary progressive MS (SPMS) with active disease.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Bristol-Myers’ earnings estimates have been revised 6.9% upward for 2018 and 6.8% for 2019 over the past 60 days.
Merck’s earnings estimates have been raised 1.6% for 2018 and 1.7% for 2019 over the past 60 days. The stock has surged 37.2% year to date.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Novartis' Gilenya Approved in EU for Expanded Population
Novartis AG (NVS - Free Report) announced that the European Commission (EC) has approved a label expansion of multiple sclerosis (MS) drug Gilenya (fingolimod).
The drug is now approved in Europe for the treatment of children who are 10-17 years old with relapsing-remitting forms of multiple sclerosis (RRMS). Following the nod, the drug became the first and only oral disease-modifying treatment for children and adolescents who experience more severe relapses than adults.
The approval was based on positive data from the phase III PARADIGMS study. Data from the study showed that Gilenya significantly reduced the relapse rates by 82% compared to interferon beta-1a. Moreover, 85.7% of patients treated with Gilenya were relapse-free for up to two years compared to interferon beta-1a. Additionally, patients experienced a 77% risk reduction of disability progression when treated with Gilenya versus patients treated with interferon beta-1a.
We note that Gilenya is already approved in the United States and Europe for treating relapsing forms of MS in patients aged 18 years or older. In May 2018, the drug was approved in the United States for the treatment of children aged 10 years or older with MS.
Shares of Novartis have gained 7% year to date compared with the industry’s growth of 7.7%.
We would like to remind investors that, in October 2018, Novartis announced encouraging top-line results from another phase IIIb ASSESS study on Gilenya.
The study evaluated the safety and efficacy of oral, once-daily Gilenya 0.5mg and 0.25mg compared with once-daily subcutaneous injections of Teva Pharmaceuticals’ (TEVA - Free Report) Copaxone (glatiramer acetate) 20mg in patients with RRMS.
The safety of Gilenya across both doses was consistent with the known safety profile of the drug. Notably, more discontinuations due to adverse events and unsatisfactory treatment effects were reported in the Copaxone group. The data from the ASSESS study further reinforces efficacy of Gilenya in treating relapsing MS.
Novartis’ MS portfolio comprises approved drugs like Gilenya and Extavia. Notably, Extavia is approved in the United States for the treatment of relapsing forms of MS. In Europe, the drug is approved to treat people with relapsing-remitting MS and secondary progressive MS (SPMS) with active disease.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the large cap pharma sector include Bristol-Myers Squibb Co. (BMY - Free Report) and Merck & Co., Inc. (MRK - Free Report) . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Merck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings estimates have been revised 6.9% upward for 2018 and 6.8% for 2019 over the past 60 days.
Merck’s earnings estimates have been raised 1.6% for 2018 and 1.7% for 2019 over the past 60 days. The stock has surged 37.2% year to date.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>