PharmaMar recently submitted a Marketing Authorization Application (MAA) for Aplidin to the European Medicines Agency (EMA).
Aplidin, combined with dexamethasone, was developed to treat relapsed or refractory multiple myeloma (MM), a type of blood cancer.
The submission of the MAA to the EMA is due to the positive results of PharmaMar’s Phase III ADMYRE clinical study, which assessed the safety and effectiveness of Aplidin, again combined with dexamethasone, compared to dexamethasone by itself. The data from the study determined that there was a reduction of 35 percent in the risk of MM progression or death due to the disease, which helped the trial meet its main goal.
"We have achieved positive results with this molecule throughout its clinical development and we believe Aplidin could become a novel therapeutic alternative for patients with multiple myeloma,” PharmaMar Oncology Business Unit Managing Director Luis Mora said. "We estimate the answer from the regulatory agency for the second half of 2017."
Aplidin has already been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Commission. PharmaMar currently has a number of licensing agreements for the sale and distribution of the medication worldwide.