Decision on EU marketing authorisation for this population expected by September 2024
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population
Imfinzi also recommended for patients with mismatch repair deficient disease
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population
Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months
Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
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