CHMP recommends six orphan medicines

EMA’s CHMP recommended seven new drugs at its April meeting: five new orphan medicines, one new “orphan hybrid,” and a non-orphan product under standard review. An orphan hybrid is similar to FDA’s 505(b)(2) application for new formulations.

Of the orphan medicines, two are up for conditional approval: Duchenne muscular dystrophy treatment Duvyzat givinostat from Italfarmaco S.p.A., and biliary tract cancer therapy Ziiher zanidatamab from Jazz Pharmaceuticals plc (NASDAQ:JAZZ)...