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DATA GRAPHICS | Data Byte

After a second look, EMA’s CHMP recommends Mirati’s KRAS inhibitor 

CHMP’s November opinions include four new medicines and an expansion of Mounjaro’s label to include obesity

November 11, 2023 12:35 AM UTC

After a re-examination of the data, EMA’s CHMP has changed its thinking on Mirati’s KRAS inhibitor, recommending approval. The decision was one of four positive opinions the committee issued for new therapies at its November meeting. Also among the highlights was a recommendation to expand the label of Lilly’s Mounjaro to include obesity. 

In July, CHMP had issued a negative opinion on Krazati adagrasib from Mirati Therapeutics Inc. (NASDAQ:MRTX) noting that the data were not comprehensive and failed to show whether the KRAS inhibitor fulfills an unmet need. ...