The board of directors of the Italian Medicines Agency (AIFA), in its November meeting, approved the admission to reimbursement by the National Health Service (SSN) of 16 drugs, including 14 active ingredients. The Agency itself made this known on 27 November 2024. The authorization granted by AIFA concerns, in the context of orphan drugs, two medicines for the treatment of rare tumors and an enzyme therapy. The approved molecules include drugs for the treatment of multiple sclerosis, atopic dermatitis, multiple myeloma, psoriasis, two enzyme therapies for Pompe disease and an antibiotic for the treatment of intra-abdominal infections that are multi-resistant to first-line treatments .
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Approval also concerns therapeutic extensions of medicines
The extensions of the therapeutic indications of medicines already reimbursed by the NHS concern the treatment of idiopathic pulmonary fibrosis, lung and thyroid cancer, and primary immune thrombocytopenia (ITP). The indications expand the treatment options for patients suffering from these pathologies, offering additional therapeutic options. Among the orphan drugs for rare diseases, AIFA has approved Omjjara (momelotinib) for the treatment of myelofibrosis, Strensiq (asfotase alfa) for pediatric-onset hypophosphatasia and Tibsovo (ivosidenib) for acute myeloid leukemia and mutated cholangiocarcinoma IDH1 R132.
Approval of new chemical entities
As for the chemical entities, AIFA has given the OK to Briumvi (ublituximab) for relapsing multiple sclerosis, Ebglyss (lebrikizumab) for atopic dermatitis, Opfolda (miglustat) and Pombiliti (cipaglucosidase alfa) for Pompe disease, Pepaxti (melphalan flufenamide) for multiple myeloma and Spevigo (spesolimab) for generalized pustular psoriasis. The antibiotic Xerava (eravacycline) has been approved for the treatment of intra-abdominal infections complicated by multidrug-resistant germs.
