The EU Has Approved Merck's Welireg® -- Green-Lit Last Year By US FDA... Immaterial, But Good Friday News.

This is nice Friday news, but many, many kidney cancer patients in the EU were already on the agent, in various clinical trials. And US patients have been receiving it since 2023, under a prior FDA clearance (see legacy graphic at right).

Fierce has the flurry of activity from across the pond, here -- and a bit:

. . .In a flurry of decisions Friday, the European Medicines Agency’s human products committee recommended 17 new drugs for approval while letting Takeda withdraw from market an inflammatory bowel disease complication medication.

Merck's kidney cancer drug Welireg, Bayer and BridgeBio’s transthyretin amyloid cardiomyopathy (ATTR-CM) therapy acoramidis, and Gilead’s primary biliary cholangitis (PBC) treatment seladelpar were among the 17 for which the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions.

For Welireg in third-line clear cell renal cell carcinoma and in tumors associated with von Hippel-Lindau disease, the CHMP is recommending a conditional marketing authorization. Both indications have counterpart approvals from the U.S. FDA. . . .

Now you know -- dinner out, in the chills, and then gallery viewing -- on Michigan Ave. with old buddies. . . smile.

नमस्ते