Six new medicines recommended for approval by EMA/CHMP

At its June meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of six new medicines, including one advanced therapy medicinal product (ATMP).

The CHMP recommended granting a conditional marketing authorization for the ATMP Zalmoxis as an adjunctive, or add-on, treatment for adult patients receiving a haploidentical hematopoietic stem cell transplant (HSCT) for types of blood cancer to aid immune reconstitution and reduce the risk of graft-versus-host disease. Zalmoxis, which has an orphan designation, is under development by Italian biotech firm MolMed (MLN: Milan).

Conditional approval allows the EMA to recommend a drug for marketing authorization before the availability of confirmatory clinical trial data, if the benefits of making this medicine available to patients immediately outweigh the risks inherent in the lack of comprehensive data. As part of the conditional marketing authorization, the applicant for Zalmoxis has to provide results from an ongoing, comparative Phase III trial which looks at disease-free survival rates. Until availability of full data, the CAT and the CHMP will review the benefits and risks of Zalmoxis annually to determine whether the conditional marketing authorization can be maintained.