The AIFA Board of Directors examined and approved in today's session the 43 dossiers submitted by the Scientific and Economic Commission for Medicines (CSE).

Of these, 5 concern the approval of new medicines:

• Inaqovi (decitabine and cedazuridine), indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia unsuitable for standard induction chemotherapy;
• Litfulo (ritlecitinib), indicated in severe alopecia areata in adults and adolescents aged 12 years and older;
• Omvoh (mirikizumab), indicated for the treatment of adult patients with moderate to severe active ulcerative colitis who have had an inadequate response, have lost response, or are intolerant to conventional therapy or biologic treatment;
• Opdualag (nivolumab/relatlimab), indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents aged 12 years or older;
• Palforzia (peanut allergen), an allergen extract for the treatment of patients aged 4-17 years with a confirmed diagnosis of peanut allergy.

All new approved medicines have been classified as Class H products for hospital use.

11 generic medicines were authorised, with an overall saving estimated at 19 million euros. An equivalent version of an important immunosuppressant (pomalidomide) was also approved, at a price reduced by 40%, for an estimated saving of 54 million euros.

Tecvayli in monotherapy, indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, was reclassified as a drug reimbursable by the NHS (Class H(OSP)).