The Food and Drug Administration (FDA) has accepted the proposal made by PharmaMar, of the Zeltia Group for the production process of Aplidin, a new marine-derived anti-tumour agent, in clinical development for the treatment of haematological and solid tumours.
The starting materials for the initiation of the production process have also been approved. Approval from the FDA confirms the strategy PharmaMar has established for the production process of Aplidin, a process that is already fully defined.
It is an FDA requirement that companies producing drugs submit full paperwork on the synthesis of their medicines. This information on the medicines synthesis together with the approval of the regulatory agency, are included in the registration dossier of a medicine.
Aplidin (Plitidepsin) is a novel anti-tumour agent discovered in the Mediterranean tunicate Aplidium albicans and currently obtained by chemical synthesis.
PharmaMar is the world-leading biopharmaceutical company of the Zeltia Group, and is committed to advancing the treatment of cancer through the discovery and development of new marine-derived medicines.