Peginterferon Beta-1a

Treats relapsing forms of multiple sclerosis (MS). Sold as Plegridy. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Peginterferon Beta-1a (sold as Plegridy), first approved Aug 15, 2014, with 2 new uses approved and 0 published complete response letters.

First approved: Aug 15, 2014
Applications: 1
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $47.5M
First approved in the EU: Jul 18, 2014

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Plegridy Pen	Part D	$39.5M	+24%	484
Plegridy	Part D	$8.0M	+42%	117

Approvals in the EU (EMA)

First approved in the EU 1 month before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Plegridy, new substanceBiogen Netherlands B.V. · Jul 18, 2014

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and SwedenMultiple Sclerosis (MS) · Bayer	—	Active, not recruiting	Sep 26, 2023
A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their BabiesMultiple Sclerosis · Biogen	—	Active, not recruiting	Jan 18, 2023
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting · Biogen	Phase 3	Active, not recruiting	May 22, 2019
Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMSMultiple Sclerosis, Relapsing-Remitting · The Cleveland Clinic	Phase 4	Active, not recruiting	May 24, 2018

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Aug 15, 2014	PlegridyBLA 125499 · New molecular entity	Biogen Idec Inc	8	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA