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
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]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/09/26 | N/A | Active, not recruiting | |||
2023/01/18 | N/A | Recruiting | |||
2019/03/12 | Phase 3 | Terminated | |||
2018/02/07 | Phase 4 | UNKNOWN | |||
2017/06/06 | Phase 4 | Completed | |||
2016/04/25 | N/A | Completed | |||
2015/10/27 | Phase 4 | Completed | |||
2015/10/05 | Phase 4 | Withdrawn | |||
2014/10/21 | Phase 1 | Completed | |||
2014/09/03 | N/A | Completed |
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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 7/18/2014 | ||
Authorised | 7/18/2014 |
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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PLEGRIDY peginterferon beta-1a (rch) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled syringe TITRATION PACK | 214198 | Medicine | A | 11/10/2014 | |
PLEGRIDY peginterferon beta-1a (rch) 125 microgram/0.5 mL solution for injection pre-filled pen | 214197 | Medicine | A | 11/10/2014 | |
PLEGRIDY peginterferon beta-1a (rch) 125 microgram/0.5 mL solution for injection pre-filled syringe | 214199 | Medicine | A | 11/10/2014 | |
PLEGRIDY peginterferon beta-1a (rch) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled pen TITRATION PACK | 214200 | Medicine | A | 11/10/2014 |
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. |
Help Us Improve
Your feedback helps us provide better drug information and insights.