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February 02, 2021 // -- Biogen recently announced that the U.S. Food and Drug Administration (FDA) has approved Plegridy (polyglycolin interferon β-1a) as a new intramuscular (IM) injection pathway for the treatment of patients with multiple sclerosis (RMS).
this new IM dosing pathway provides good efficacy and safety, has the ability to reduce recurrence and delays progression of disability, and has the potential to significantly reduce injection point response.
in the European Union, the Plegridy intramyal injection route was approved in December 2020.
multiple sclerosis (MM) is an autoimmune disease that affects more than 2.3 million people worldwide.
this approval expands Yan Jian's industry-leading portfolio in multiple sclerosis treatment, including subskin (SC) injection type Plegridy, and expands treatment options for MS patients.
Plegridy is the only polyethyl glycol interferon approved for multiple sclerosis (MS), which has the ability to delay progression and reduce recurrence of disability.
Plegridy was first approved by the FDA in 2014 and has been shown to significantly reduce MS recurrence, disability progress and brain damage, as well as good safety and tolerance.
, Plegridy is available in more than 60 countries around the world.
FDA-approved Plegridy IM administration pathway is based on data assessing the bioethics and adverse reactions associated with IM administration and subdern (SC) injection administration in healthy volunteers.
results confirmed that the two dosing programmes were biologically equivalent and that subjects who were given IM had fewer injection site reactions (14.4% vs 32.1%) than subjects who were given SC.
the overall safety status was similar, and the rate of reactions and adverse events at the injection site was comparable between subjects of IM-after-SC and subjects of first-SC-after-IM.
, Chief Medical Officer, maha Radhakrishnan, said, "At Yanjian, we are committed to continuous innovation to provide MS patients with more choices to meet their individual preferences and needs.
Plegridy is a proven effective treatment for multiple sclerosis, which will provide a different method of administration for patients with multiple sclerosis, with the potential to significantly reduce injection site response.
() Original source: Biogen Announces FDA approval of PLEGRIDY (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis