BRIEF—Extended indications backed at March EMA/CHMP meeting

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) at its March 2018 meeting, as well as approving first use of  six new drugs, recommended extensions of indications for three already marketed drugs.

The Committee provided a positive opinion for French drugmaker Ipsen’s Cabometyx(cabozantinib) 20mg, 40mg, 60mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC).

The CHMP also recommended an extension of the indication for Merck & Co’s Ivemend (fosaprepitant; US trade name Emend) to cover the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and pediatric patients aged 6 months and older.

It also recommended that Amgen’s Repatha (evolocumab) is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors.