March EMA/CHMP meeting sees five positive novel drugs recommended

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended five novel medicines for approval at its March 2021 meeting. A final decision on the approval by the European Commission is usually issues in about two-three months.

The Committee recommended granting a marketing authorization for Copiktra (duvelisib), from US biotech Verastem Oncology (Nasdaq: VSTM), for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or refractory follicular lymphoma (FL). In August last year, Verastem sold worldwide rights to Copiktra, the first Food and Drug Administration-approved dual inhibitor of PI3K-delta and PI3K-gamma, to Secura Bio, an integrated biopharmaceutical company.

The CHMP adopted a positive opinion for Ponvory (ponesimod), from Johnson & Johnson (NYSE: JNJ) unit Janssen, for the treatment of active relapsing forms of multiple sclerosis. If approved, ponesimod will be the first therapy by Janssen for patients living with RMS with active disease defined by clinical or imaging features. The US FDA approved ponesimod for use in adults with relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in March 2021.