Orphelia Pharma files for EU marketing authorization of Kizfizo

Privately-held French company Orphelia Pharma, which is focused on pediatric and orphan medicines, has filed a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kizfizo, the first oral liquid formulation of temozolomide, the active ingredient of Merck & Co’s (NYSE: MRK) Temodar.

Kizfizo, known as Ped-TMZ or Kimozo during its clinical development and ongoing early access programs, is designed specifically for use in the treatment of children with relapsed or refractory neuroblasto+ma, oncology indications with a very poor prognosis. This oral suspension, which is taste-masked, was developed for children: it allows a precise dose to be administered orally or via a nasogastric tube in a small volume.

Orphelia Pharma has been developing Kizfizo in collaboration with Gustave Roussy, the leading European cancer center, for the last six years. It has an agreement with Tanner Pharma to manage the supply and distribution of the drug.