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Alkermes, Biogen Submit NDA to FDA for Multiple Sclerosis Drug
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Alkermes Plc. (ALKS - Free Report) and partner Biogen (BIIB - Free Report) announced that they have submitted a new drug application (NDA) to the FDA for diroximel fumarate (BIIB098), a novel oral fumarate being developed for the treatment of relapsing forms of multiple sclerosis (MS).
The NDA submission was supported by data from EVOLVE-1, a phase III study that evaluated long-term safety in relapsing-remitting MS (RRMS) in about 700 patients dosed with diroximel fumarate. EVOLVE-1 is a two year study in RRMS patients along with pharmacokinetic bridging studies comparing diroximel fumarate and dimethyl fumarate. Further, Alkermes is also conducting the EVOLVE-MS-2 study, a five-week, head-to-head gastrointestinal (GI) tolerability study versus dimethyl fumarate.
Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may have the potential to offer differentiated GI tolerability due to its chemical structure as compared to dimethyl fumarate.
Share price of Alkermes has decreased 39.8% compared with the industry’s decline of 21.4% year to date.
If approved, Biogen plans to market diroximel fumarate under the brand name Vumerity. This name has been conditionally accepted by the FDA and will be confirmed upon approval.
MS is a promising market and there are many companies already having drugs in their portfolio approved for this indication. Biogen holds a strong position in the MS market with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy. Israel-based Teva Pharmceuticals (TEVA - Free Report) has long been in the MS market through its widely used drug Copaxone, which is facing stiff competition for the past few years.
Novartis’ (NVS - Free Report) 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. 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.
The greatest discovery in this century of biology is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating revenue, and cures for a variety of deadly diseases are in the pipeline.
So are big potential profits for early investors. Zacks has released an updated Special Report that explains this breakthrough and names the best 3 stocks to ride it.
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Alkermes, Biogen Submit NDA to FDA for Multiple Sclerosis Drug
Alkermes Plc. (ALKS - Free Report) and partner Biogen (BIIB - Free Report) announced that they have submitted a new drug application (NDA) to the FDA for diroximel fumarate (BIIB098), a novel oral fumarate being developed for the treatment of relapsing forms of multiple sclerosis (MS).
The NDA submission was supported by data from EVOLVE-1, a phase III study that evaluated long-term safety in relapsing-remitting MS (RRMS) in about 700 patients dosed with diroximel fumarate. EVOLVE-1 is a two year study in RRMS patients along with pharmacokinetic bridging studies comparing diroximel fumarate and dimethyl fumarate. Further, Alkermes is also conducting the EVOLVE-MS-2 study, a five-week, head-to-head gastrointestinal (GI) tolerability study versus dimethyl fumarate.
Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may have the potential to offer differentiated GI tolerability due to its chemical structure as compared to dimethyl fumarate.
Share price of Alkermes has decreased 39.8% compared with the industry’s decline of 21.4% year to date.
If approved, Biogen plans to market diroximel fumarate under the brand name Vumerity. This name has been conditionally accepted by the FDA and will be confirmed upon approval.
MS is a promising market and there are many companies already having drugs in their portfolio approved for this indication. Biogen holds a strong position in the MS market with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy. Israel-based Teva Pharmceuticals (TEVA - Free Report) has long been in the MS market through its widely used drug Copaxone, which is facing stiff competition for the past few years.
Novartis’ (NVS - Free Report) 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. 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.
Alkermes plc Price
Alkermes plc Price | Alkermes plc Quote
Zacks Rank
Alkermes currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
3 Medical Stocks to Buy Now
The greatest discovery in this century of biology is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating revenue, and cures for a variety of deadly diseases are in the pipeline.
So are big potential profits for early investors. Zacks has released an updated Special Report that explains this breakthrough and names the best 3 stocks to ride it.
See them today for free >>