FDA Approves Peginterferon Beta-1a Intramuscular Administration for Multiple Sclerosis
The new administration option for multiple sclerosis treatment could improve access during the COVID-19 pandemic, when availability has been a concern.
Intramuscular injection of peginterferon beta-1a (Plegridy, Biogen) has been approved for the treatment of relapsing multiple sclerosis (MS) as an option with significantly reduced injection site reactions, according to a press release.
Plegridy is the only approved pegylated interferon for MS with a proven ability to delay progression of MS disability and reduce relapses, according to the press release. It was first approved in 2014 and has a well-understood safety and tolerability profile. This new administration option offers patients with MS the pre-established efficacy and safety of Plegridy with the potential for fewer injection site reactions.
MS is an autoimmune disorder affecting more than 2.3 million people worldwide. Access to treatment options has become increasingly important during the coronavirus disease 2019 (COVID-19) pandemic, making the addition of an intramuscular injection option even more vital.
According to the press release from Biogen, the FDA approval is based on data evaluating bioequivalence and adverse reactions associated with intramuscular administration compared with subcutaneous administration in healthy volunteers. In addition to confirmed bioequivalence between the 2 dosing regimens, the study found that participants receiving Plegridy intramuscularly experienced fewer injection site reactions in comparison to patients receiving subcutaneous administration (14.4% v. 32.1%).
The safety and efficacy of Plegridy are supported by one of the largest pivotal studies with interferons conducted in individuals living with relapsing-remitting MS. In clinical trials, it has been proven to significantly reduce the rate of MS relapses, slow the progression of disability, and reduce the number of MS brain lesions.
Adverse effects (AEs) reported include liver problems, depression or suicidal thoughts, serious allergic reactions, injection site reactions, cardiac problems, blood problems, autoimmune disorders, and seizures. The most common AEs were injection site reactions and flu-like symptoms.
“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,” said Maha Radhakrishnan, MD, chief medical offer at Biogen, in a statement.
Biogen Announces FDA Approval of Plegridy (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis [news release]. Biogen; February 1, 2021. https://investors.biogen.com/news-releases/news-release-details/biogen-announces-fda-approval-plegridyr-peginterferon-beta-1a. Accessed February 1, 2021.