Nilotinib Accord is a generic version of Tasigna, which has received EU authorization since 2007

Release date: 2024-08-19 10:31:45     Recommended: 316

On June 27, 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use issued a favorable opinion recommending the approval of a marketing authorization for the medicinal product Nilotinib Accord (nilotinib), intended for treating chronic myelogenous leukemia (CML).

The applicant for this medicine is Accord Healthcare S.L.U.

Nilotinib Accord will be available in hard capsules of 50 mg, 150 mg, and 200 mg. The active ingredient is nilotinib, an antineoplastic protein kinase inhibitor (ATC code: L01EA03) that acts to inhibit the activity of BCR-ABL kinase and other specific oncogenic kinases.

Nilotinib Accord is a generic version of Tasigna, which has been authorized in the EU since November 19, 2007. Studies have confirmed the satisfactory quality of Nilotinib Accord and demonstrated its bioequivalence to the reference product Tasigna.

The full indications for use are as follows:

Nilotinib Accord is indicated for:

1. Adult and pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukemia (CML) in the chronic phase.

2.Adult patients with chronic phase and accelerated phase Philadelphia chromosome-positive CML who show resistance or intolerance to prior therapies, including imatinib. Efficacy data for patients with CML in blast crisis are not available.

3. Pediatric patients with chronic phase Philadelphia chromosome-positive CML who have resistance or intolerance to prior therapy, including imatinib.

Nilotinib Accord should be prescribed by physicians experienced in treating patients with CML.

Detailed usage recommendations for this product will be outlined in the summary of product characteristics, which will be published in the European public assessment report and made available in all official EU languages following the granting of marketing authorization by the European Commission.

Summaries of positive opinions are published without prejudice to the Commission's final decision, which is typically issued 67 days after the opinion has been adopted.