Bristol-Myers Squibb Company — Vidaza EMA EPAR public assessment report (EMEA/H/C/000978, 2008)
Bristol-Myers Squibb Company · 2008 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Vidaza (azacitidine) led to marketing authorization in October 2008 for specific indications in Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), and Acute Myeloid Leukemia (AML). Vidaza, an orphan medicinal product, demonstrated significant efficacy in a pivotal Phase 3 study (AZA-001) for MDS patients. It significantly improved median overall survival (24.46 months vs 15.02 months for conventional care) and time to death or AML transformation. The safety profile is acceptable, with common adverse events being hematological (thrombocytopenia, neutropenia, anemia), gastrointestinal, and injection site reactions. Serious adverse events included febrile neutropenia and pneumonia.
Key findings — cited to the page
| patients with Grade 3/4 TEAE (azacitidine) | 91.4 % | · p.39 |
| patients with Grade 3/4 TEAE (BSC only) | 75.5 % | · p.39 |
| Marketing Authorisation date | 24/02/2006 | Vidaza · Switzerland · p.3 |
| Orphan medicinal product designation date | 06 February 2002 | Vidaza · EU · p.3 |
| Calculated prevalence of AML | less than 2 in 10,000 persons | EU · p.3 |
| Calculated prevalence of MDS | 1.1 to 3 in 10,000 persons | EU · p.3 |
| Marketing Authorisation date | 25.03.2007 | Vidaza · Hong Kong · p.3 |
| Marketing Authorisation date | 09.11.2007 | Vidaza · Argentina · p.3 |
| Marketing Authorisation date | 27.01.2006 | Vidaza · South Korea · p.3 |
| Marketing Authorisation date | 19.5.2004 | Vidaza · United States · p.3 |
| Marketing Authorisation date | 10.10.2007 | Vidaza · Thailand · p.3 |
| European Commission Decisions adoption date | 17 December 2008 | EU · p.4 |
Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →