Current regulatory status
The regulatory status provides current information on the Company’s marketing authorizations and regulatory submissions.
Pepaxti has been granted Marketing Authorization in the European Union, including the EEA-countries Iceland, Lichtenstein and Norway, by the European Commission on August 17, 2022. The product was approved by the Medicines and Healthcare products Regulatory Agency, MHRA, in the UK on November 11, 2022.
Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.