CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer’s drug

CHMP March 2025 Meeting Outcomes:
Label Expansions, New Approval, and Alzheimer's Drug Rejection

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued recommendations for several drugs at its March 2025 meeting1 4:

Label Expansions

Seven drugs received recommendations for label expansions:

Bristol Myers Squibb's Opdivo (nivolumab) and Yervoy (ipilimumab) combination for first-line treatment of unresectable hepatocellular carcinoma2
Vertex's Kaftrio and Kalydeco combination for cystic fibrosis in patients 2 years and older4
Novartis' Fabhalta for C3 glomerulopathy4
AbbVie's Rinvoq for giant cell arteritis4
Eli Lilly's Jaypirca for chronic lymphocytic leukemia4
Valneva's Ixchiq vaccine for chikungunya in patients 12 years and older4

New Approval

The CHMP recommended approval for one new drug:

Xoanacyl (ferric citrate coordination complex) for treating hyperphosphatemia and iron deficiency in adults with chronic kidney disease3

Alzheimer's Drug Rejection

The CHMP rejected Eli Lilly's Alzheimer's drug donanemab (branded as Kisunla) due to safety concerns5 11. The committee cited the risk of potentially fatal brain swelling and bleeding side effects known as amyloid-related imaging abnormalities (ARIA)5. In clinical trials, ARIA occurred in 36.8% of patients taking donanemab compared to 14.9% on placebo, with 1.6% experiencing serious ARIA events and three patient deaths5.

This rejection follows a similar path to Biogen/Eisai's Leqembi, which initially failed to secure CHMP approval but later received a restricted recommendation5.