Five new medicines recommended for approval by EMA/CHMP

Five new medicines have been recommended for approval at the March 2015 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The CHMP has recommended granting a marketing authorization for Japanese drug major Eisai’s (TYO: 4523) Lenvima (lenvatinib) for the treatment of adults with progressive, locally advanced or metastatic differentiated thyroid carcinoma, whose disease has progressed despite receiving radioactive iodine.

Lenvima was reviewed under EMA’s accelerated assessment program. This program provides for an expedited review of medicines that, if approved, would significantly improve the treatment of this serious condition. The medicine also received an orphan designation in 2013 because the condition it is intended to treat was considered a rare disease. For more information on Lenvima, please see the press release in the grid below.