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A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults

Trial Profile

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Dec 2021

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At a glance

  • Drugs Diroximel-fumarate (Primary) ; Dimethyl fumarate
  • Indications Multiple sclerosis
  • Focus Adverse reactions
  • Sponsors Alkermes plc; Biogen
  • Most Recent Events

    • 16 Nov 2021 According to a Biogen media release, the European Commission (EC) has granted marketing authorization for VUMERITY (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS).
    • 17 Sep 2021 According to a Biogen media release, the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), issued a positive opinion and has recommended granting marketing authorization for VUMERITY (diroximel fumarate) in the European Union (EU). The positive CHMP opinion was based on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA(dimethyl fumarate). This opinion will now be referred to the European Commission(EC).
    • 27 Apr 2018 Results (n=35) evaluating pharmacokinetics presented at the 70th Annual Meeting of the American Academy of Neurology
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