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Peginterferon beta-1a

Generic Name
Peginterferon beta-1a
Brand Names
Plegridy
Drug Type
Biotech
CAS Number
1211327-92-2
Unique Ingredient Identifier
I8309403R0

Overview

Multiple Sclerosis (MS) is a chronic and inflammatory autoimmune disease of the central nervous system, disrupting communication between the brain and other parts of the body. Most patients diagnosed with this illness experience their initial disease symptoms between the age of 20 to 40, often the most productive years of life. Symptoms may include but are not limited to fatigue, gait changes, bowel or bladder dysfunction, abnormal muscle twitching, vision disturbance, and depressing or mood swings. MS is one of the most common causes of neurological disability in young adults and is found to occur more frequently in women than in men. Peginterferon beta-1a is an interferon therapy used for the management of relapsing forms of MS. It was originally approved by the FDA in 2014 for subcutaneous use, and was approved for intramuscular use in January 2021. Currently, it is the only approved pegylated interferon for the management of MS with an proven ability to reduce relapses and delay the progression of disability resulting from MS.

Indication

Peginterferon beta-1a is indicated for the treatment of adult patients with relapsing forms of MS, including relapsing-remitting disease, clinically isolated syndrome, and active progressive secondary disease.

Associated Conditions

  • Multiple Sclerosis

Research Report

Published: Aug 21, 2025

Peginterferon Beta-1a (Plegridy®): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Therapeutic Role in Multiple Sclerosis

Introduction and Drug Profile

The Clinical Challenge of Multiple Sclerosis (MS)

Multiple sclerosis (MS) is a chronic, immune-mediated, and neurodegenerative disorder of the central nervous system (CNS) that represents a significant global health challenge.[1] The pathophysiology of MS is characterized by a complex interplay of inflammation and demyelination, wherein the body's own immune system erroneously targets and attacks the myelin sheath—the protective covering of nerve fibers in the brain, spinal cord, and optic nerves.[1] This autoimmune assault disrupts the normal transmission of nerve impulses, leading to a wide spectrum of debilitating neurological symptoms. These can include, but are not limited to, profound fatigue, alterations in gait and balance, bladder and bowel dysfunction, vision disturbances, abnormal muscle spasticity, and significant mood swings, including depression.[1]

MS is one of the most common causes of non-traumatic neurological disability in young adults, with a notable predilection for women over men.[1] The clinical course of the disease is heterogeneous, but the majority of patients are initially diagnosed with a relapsing-remitting form (RRMS), characterized by acute episodes of neurological dysfunction (relapses) followed by periods of partial or complete recovery (remissions).[3] Over time, many patients with RRMS may transition to a secondary progressive phase (SPMS), marked by a steady accumulation of disability, with or without superimposed relapses.[3]

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Biogen Inc.
64406-015
SUBCUTANEOUS
125 ug in 0.5 mL
11/11/2022
Biogen Inc.
64406-011
SUBCUTANEOUS
125 ug in 0.5 mL
11/11/2022
Biogen Inc.
64406-017
INTRAMUSCULAR
125 ug in 0.5 mL
11/11/2022

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PLEGRIDY
Biogen Canada Inc
02444402
Liquid ,  Kit - Subcutaneous
63 MCG / 0.5 ML
9/25/2015
PLEGRIDY
Biogen Canada Inc
02444402
Liquid ,  Kit - Subcutaneous
94 MCG / 0.5 ML
9/25/2015
PLEGRIDY
Biogen Canada Inc
02444399
Liquid - Subcutaneous
125 MCG / 0.5 ML
9/29/2015
PLEGRIDY
Biogen Canada Inc
02444380
Liquid - Subcutaneous
94 MCG / 0.5 ML
N/A
PLEGRIDY
Biogen Canada Inc
02444372
Liquid - Subcutaneous
63 MCG / 0.5 ML
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
Plegridy 125 microgramos SOLUCION INYECTABLE EN JERINGA PRECARGADA SC
114934003
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized
Plegridy 63 94 microgramos solucion inyectable en jeringa precargada
114934001
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized
PLEGRIDY 125 microgramos SOLUCION INYECTABLE EN JERINGA PRECARGADA IM
114934007
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized
Plegridy 63 94 microgramos solucion inyectable en pluma precargada
114934002
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Uso Hospitalario
Commercialized
Plegridy 125 microgramos solucion inyectable en pluma precargada
114934005
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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