Press release No. 19/2024 - The AIFA Board of Directors, in its September and October meetings, approved 6 medicines, including new molecules, generic medicines, extensions of therapeutic indications and new packages of medicines already authorised.

Among these, a new medicine to be used as an add-on therapy to the standard treatment for generalised myasthenia gravis, a generic medicine indicated for the treatment of adults with chronic myeloid leukaemia, an extension of the therapeutic indications of a medicine for the treatment of HIV type 1.

The following medicines have been authorised and admitted to reimbursement by the NHS:

New medicine:

• Zilbrysq (zilucoplan), an add-on therapy to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients positive for anti-acetylcholine receptor (AChR) antibodies.

Extension of therapeutic indications:

• Biktarvy (Bictegravir/emtricitabine/tenofovir alafenamide fumarate), treatment of human immunodeficiency virus type 1 (HIV 1) infection. The indication has been extended to the paediatric population aged 2 years and older and with a body weight of at least 14 kg.

Generic medicine:

• Nilotinib Accord (nilotinib), treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (CML).

New packages of the medicines Deferasirox Glenmark (deferasirox), for the treatment of chronic iron overload, Opzelura (Ruxolitinib), for vitiligo, Proplex (Factors IX, II, VII and X in combination), for the treatment and prophylaxis of bleeding, have also been authorised.

N.B. The therapeutic indications of the medicines mentioned are reported in full in the attachments to this press release.

Published on: 23 October 2024