Treats relapsing forms of multiple sclerosis (MS). BLA 125499, held by Biogen Idec Inc. Peginterferon Beta-1a.
As of Nov 13, 2026, BLA 125499 (Plegridy), held by Biogen Idec Inc, was first approved by FDA on Aug 15, 2014, with 8 approved supplements and 0 published complete response letters.
PLEGRIDY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 29, 2021 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Mar 27, 2020 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Aug 15, 2014 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Plegridy125MICROGRAMS/0.5ML · injectable;injection | Peginterferon Beta-1a | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2023 | Supplement 28Labeling · Standard review | Approved | |
| Mar 29, 2022 | Supplement 25Labeling · Standard review | Approved | |
| Nov 3, 2021 | Supplement 23Labeling · Standard review | Approved | |
| Jan 29, 2021 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Mar 27, 2020 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 2019 | Supplement 19Labeling · Standard review | Approved | |
| Jul 14, 2016 | Supplement 11Labeling · Standard review | Approved | |
| Dec 22, 2015 | Supplement 9Labeling · Standard review | Approved | |
| Aug 15, 2014 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
