Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats essential thrombocythemia. Sold as Besremi. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Ropeginterferon Alfa-2b-Njft (sold as Besremi), first approved Nov 12, 2021, with 1 new use approved and 1 published complete response letter.
First approved: Nov 12, 2021
Applications: 1
New uses approved: 1
Complete response letters: 1
Medicare spending, 2025: $163M
Orphan exclusivity until: Nov 12, 2028
First approved in the EU: Feb 15, 2019
First approved in Japan: Mar 27, 2023
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 16 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Besremi, new ingredientDrugs with a new active ingredient indicated for the treatment of polycythaemia vera (use only when conventional therapies are not sufficiently effective or… · PharmaEssence Japan K.K. · Mar 27, 2023
Clinical Trials
2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
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
