BAFIERTAM
Peakmonomethyl fumarate
NDAORALCAPSULE, DELAYED RELEASE
Approved
Apr 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
7/8 — Comprehensive
BAFIERTAM (monomethyl fumarate) is (mmf) exerts its therapeutic effect in multiple sclerosis is unknown. Approved for relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease and 2 more indications. First approved in 2020.
Drug data last refreshed 4d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BAFIERTAM (monomethyl fumarate) is an oral delayed-release capsule approved in 2020 for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The mechanism of action is not fully understood but involves activation of the Nrf2 pathway (cellular response to oxidative stress) and nicotinic acid receptor agonism.
$0.005BPart D
Peak8.8 years to LOEEarly peak-stage product with modest Medicare spending ($5M) and limited market penetration suggests smaller commercial team relative to established competitors.
Mechanism of Action
(MMF) exerts its therapeutic effect in multiple sclerosis is unknown. MMF has been shown to activate the Nuclear factor (erythroid-derived 2) like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been…
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.