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
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2015/10/05 | Phase 4 | Withdrawn | |||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 |
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