Plegridy intramuscular injection offers a treatment option with reduced injection site reactions for individuals with relapsing multiple sclerosis (MS)
Biogen gets FDA approval for Plegridy IM administration. (Credit: Arek Socha from Pixabay.)
US-based biotechnology firm Biogen has secured the US Food and Drug Administration (FDA) approval for intramuscular (IM) administration of Plegridy (peginterferon beta-1a) to treat relapsing forms of multiple sclerosis (MS).
The new IM administration is said to offer the efficacy and safety of Plegridy with significantly reduced injection site reactions for people living with relapsing MS.
The FDA approval follows the EC marketing authorisation for the IM administration of Plegridy, granted in December 2020.
Also, the approval expands the company’s portfolio of MS treatments, which includes the subcutaneous (SC) administration of Plegridy.
Biogen chief medical officer Maha Radhakrishnan said: “At Biogen, we are committed to continued innovation to give people with MS more choices and more options to meet their individual preferences and needs.
“Plegridy is a proven, effective therapy for relapsing MS, and this approval gives new and current MS patients a different delivery method that has the potential to significantly reduce injection site reactions.”
Plegridy is a pegylated interferon dosed once every two weeks for relapsing forms of MS in adults and is currently approved in more than 60 countries including the US, Canada, Australia and Switzerland and across the EU.
The drug was first approved by the FDA in 2014 to reduce MS relapses, disability progression and brain lesions, with well-established safety and tolerability profile.
Current FDA approval of IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers.
The bioequivalence between the two dosing regimens was established and the data demonstrated that Plegridy via IM administration reduced the injection site reactions compared to SC administration.
Also, Plegridy IM injection showed a generally similar overall safety profile, with no new safety signals observed.
Biogen claimed that its Plegridy is the only approved pegylated interferon targeting MS with the potential to delay the progression of MS disability and reduce relapses.