Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA Board approves reimbursement of 10 drugs - AIFA Board approves reimbursement of 10 drugs

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AIFA Board approves reimbursement of 10 drugs

The Board of Directors of the Italian Medicines Agency, in its meeting of 2 April 2025, decided to admit 10 medicines to reimbursement by the National Health Service, including orphan drugs for rare diseases (1), new chemical molecules (1), generic medicines (3) and extensions of therapeutic indications (5).

The orphan drug that will be reimbursed by the NHS is Rystiggo (rozanolixizumab), indicated as an additional therapy to standard therapy for the treatment of generalised myasthenia gravis, an autoimmune neuromuscular disease that causes severe muscle weakness.

The new chemical entity that will be admitted to reimbursement is Elrexfio (elranatamab), indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma.

The three generic medicines admitted to reimbursement are: Eltrombopag Viatris (eltrombopag), for the treatment of adults and children with primary immune thrombocytopenia (ITP) and for the treatment of thrombocytopenia in adults with hepatitis C; Pazopanib Mylan (pazopanib), for the treatment of certain subtypes of soft tissue sarcoma (STS); Somingatim eye drops (tafluprost and timolol maleate), indicated in adult patients with open-angle glaucoma or ocular hypertension.

The extensions of therapeutic indication concern: the anticancer medicine Alecensa (alectinib); the medicine for the symptomatic treatment of endometriosis Ryeqo (Relugolix/estradiol/norethisterone acetate); the selective immunosuppressant based on a monoclonal antibody for generalised myasthenia gravis Soliris (eculizumab); the antibiotic for the treatment of acute bacterial skin infections Xydalba (dalbavancin); the monoclonal antibody for the treatment of bone diseases Crysvita (burosumab).


Published on: 03 April 2025

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