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Biogen Reports Interim Phase III Data on Diroximel Fumarate

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Biogen Inc. BIIB announced the new interim data from the ongoing, open-label, pivotal phase III EVOLVE-MS-1 study, which showed that the investigational treatment diroximel fumarate was generally well tolerated in people with relapsing multiple sclerosis (MS). Diroximel fumarateis a novel oral fumarate, which has been developed for the treatment of relapsing forms of MS. The candidate is under FDA review and the agency has set an action date in the fourth quarter of 2019. The candidate is being developed in collaboration with Alkermes plc ALKS. If approved, both the companies plan to market diroximel fumarate under the brand name, Vumerity.

The EVOLVE-MS-1 study is evaluating the safety and efficacy of diroximel fumarate in patients with relapsing-remitting MS. Researchers explored the efficacy of the candidate in a sub-group analysis of the study that included patients, who were naive to prior disease-modifying therapy treatment or those previously treated with an interferon (IFN) or glatiramer acetate (GA). New results, in patients treated with prior IFN/GA, showed that the candidate was associated with significant improvements in radiological and clinical endpoints over one year compared to baseline. Adjusted annualized relapse rate was reduced by 72% with diroximel fumarate between baseline and Week 48. Further, the candidate also demonstrated a reduction in the mean number of gadolinium-enhancing (Gd+) lesions by 64% compared to baseline, and the percentage of patients with no Gd+ lesions at Week 48 was 89% compared to 74% at baseline.

Additional new data illustrated the tolerability profile of the candidate in relapsing-remitting MS patients over one year. In the study, diroximel fumarate demonstrated low rates of gastrointestinal (GI) adverse events leading to discontinuation (0.7%).

Shares of Biogen have declined 24.6% year to date, against the industry’s growth of 0.2%.

MS is a crowded market, with 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 has long been in the MS market with its widely used drug Copaxone, which is facing stiff generic competition for the past few years.

Novartis’ NVS MS portfolio comprises approved drugs like Gilenya and Extavia for the treatment of relapsing forms of MS.

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Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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