The AIFA Board of Directors examined and approved 38 dossiers for which the Scientific and Economic Commission for Medicinal Products (SEC) completed the assessment process (Annex 1).
The new authorised medicinal products are of particular relevance. These are 4 orphan drugs for rare diseases, 5 drugs based on new active ingredients, and 6 extensions of therapeutic indications.
The orphan drugs authorised and eligible for reimbursement by the NHS are indicated for the treatment of the following pathologies (Annex 2):

• Enjaymo (sutimlimab), for haemolytic anaemia in adult patients with cold agglutinin disease (CAD)
• Tepkinly (epcoritamab), as monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
• Finlee (dabrafenib), in combination with trametinib for the treatment of low-grade and high-grade glioma in paediatric patients
• Spexotras (trametinib), in combination with dabrafenib for the treatment of low-grade and high-grade glioma in paediatric patients.

The other drugs authorised and eligible for reimbursement by the NHS are indicated for the treatment of the following pathologies (Annex 2):

• Erwinase (crysantaspase), in combination with other chemotherapy medicines to treat patients, mainly children, with acute lymphoblastic leukaemia
• Jaypirca (pyrtobrutinib), as monotherapy to treat adult patients with mantle cell lymphoma
• Yselty (linzagolix choline), to treat symptoms of uterine fibroids 
• Locametz (gozetotide), medicinal product for diagnostic use
• Aquipta (atogepant), indicated for prophylaxis of migraine in adults.
• Pyzchiva (ustekinumab), a monoclonal antibody for psoriasis, has also been authorised.

The BoD also approved the list of medicines authorised under the simplified procedure (equivalent medicines and parallel import products).