2021-02-02| Trials & Approvals

Biogen Strengthens its Grip on the Multiple Sclerosis Market with Another FDA Approval

by Tulip Chakraborty
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Multiple Sclerosis (MS), an autoimmune, is a progressive neurodegenerative disorder characterized by loss of the protective myelin sheath on nerve fibers. Currently, 1 million people in the United States and 2.3 million people worldwide suffer from this chronic disorder. Given the ongoing pandemic and the lack of essential treatment, MS patients are looking for easier ways to administer their drugs with fewer side effects.

On February 1st Biogen announced that their blockbuster drug, Plegridy, received the nod from the US food and drug administration (USFDA) for intramuscular administration of the drug in patients with relapsing MS.

Dr. Maha Radhakrishnan, the Chief Medical Officer, 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 the first of its kind pegylated interferon-1 treatment approved for relapsed MS patients in 60 different countries. First approved in 2014, Plegridy boasts of significantly reducing MS progression, brain lesions, and relapses.

This current FDA approval is based on adverse reactions associated with intramuscular injections and subcutaneous injections. Intramuscular injections resulted in 14.4 % of patients experiencing injection site reactions, compared to 32.1% in the subcutaneous group. The safety profiles were similar in both routes of administration.



Biogen has been the frontrunner among the pharmaceutical giants in the field of MS treatments. Biogen’s Plegridy has maintained its grip over the market with a $2.9 billion net value and $1 billion revenue in 2020.

With the COVID-19 pandemic still at its peak, adding a safer route of administration to its portfolio will further enhance Biogen’s position. Biogen’s primary competition comes from Merck’s Rebif, Roche’s Ocrevus, Novartis’ Ofatumumab, and Sanofi’s Lemtrada.

Of this, Roche’s Ocrevus has recently shown to be effective against relapsing-remitting Multiple Sclerosis. The advantage of Ocrevus is, it has to be administered twice yearly, while Plegridy has to be injected once in two weeks. Though Biogen, for now, has increased its lead over the competition, it is to be seen if any of the other pharmaceutical giants can narrow the gap.

Related Article: Novartis’ Kesimpta Notches FDA Approval as Targeted B-cell Therapy for Patients with Relapsing MS



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