Daurismo (glasdegib)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- glasdegib
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid, Acute
- CHMP opinion
- Thu 30 Apr 2020
- EU approval
- Fri 26 Jun 2020
- Designations
- Orphan
- Application
- EMEA/H/C/004878
- ATC
- L01XX63
- Official record
- www.ema.europa.eu
Indication
Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.