CHMP against Emmaus' sickle cell therapy, Taiwan Liposome's doxorubicin

EMA's CHMP issued several opinions Wednesday, including a negative opinion for Emmaus' sickle cell disease therapy, and on re-examination, a negative recommendation for Taiwan Liposome's breast and ovarian cancer treatment.

The agency recommended against approval of Xyndari glutamine from Emmaus Life Sciences Inc. (Torrance, Calif.) to treat sickle cell disease. CHMP said Xyndari's main study did not show that the therapy was effective at reducing the number of sickle cell crises or hospital visits. The orally administered pharmaceutical grade L-glutamine is marketed in the U.S. as Endari...