New monoclonal antibody therapies launched in Spain and Argentina

New monoclonal antibody treatments have been introduced in Spain and Argentina to address specific rare diseases.

In Spain, Johnson & Johnson has released nipocalimab (IVAAVY) for the treatment of generalized myasthenia gravis (gMG). Approved for adults and adolescents aged 12 and older with AChR or MuSK antibody positivity, the drug acts as an Fc neonatal receptor (FcRn) blocker. It is administered intravenously, with maintenance doses required every two weeks. The treatment has received price and reimbursement approval within the Spanish National Health System.

In Argentina, Pfizer has launched marstacimab following approval by ANMAT. This therapy is indicated for preventing bleeding episodes in patients aged 12 and older with severe hemophilia A or B who do not have inhibitors. Unlike traditional intravenous factor replacement therapies, marstacimab is a subcutaneous injection administered once weekly via a pre-filled pen, allowing for administration by patients or caregivers.