JERUSALEM - (Business Wire) Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today the successful completion of ADAGIO, the phase III study designed to demonstrate that AZILECT® 1 mg tablets can slow down the progression of Parkinson's disease. In the trial, the currently marketed AZILECT® 1 mg tablets met all three primary end points, as well as the secondary and additional end points, all with statistical significance. The study also confirmed the safety and tolerability of AZILECT®.
Teva intends to submit these results to the regulatory authorities in the U.S. and Europe. Based on these results, AZILECT® could become the first Parkinson's disease treatment to receive a label for disease modification.
Teva's Chief R&D Officer, Dr. Ben-Zion Weiner, stated: "This scientific breakthrough addresses one of the most critical unmet needs in the treatment of patients with Parkinson's disease."
Shlomo Yanai, President and Chief Executive Officer of Teva, added, "This achievement demonstrates the strength of Teva's innovative R&D capabilities and highlights our continued commitment to the development of treatments for the more challenging areas of neurological diseases. These positive results could dramatically increase the market potential for AZILECT®, allowing AZILECT® to join COPAXONE® as another major Teva drug for neurological disorders."
The study protocol was based on the recommendations and guidance of the U.S. Food and Drug Administration. The 18-month study, the first of its kind, is one of the largest conducted in Parkinson's disease, involving 1,176 patients with early Parkinson's disease in 14 countries and 129 medical centers.
In addition, the 2 mg dose in the study met two of the three primary end points as well as the secondary end point. The 2 mg dose was also found to be safe and well tolerated.
More detailed data analysis will take place over the coming weeks and will be presented to the medical community at a later date.
En pocas palabras:
- ha finalizado el ensayo clínico fase III del Azliect y se han demostrado estadísticamente todos los supuestos del estudio : eficacia, seguridad y tolerabilidad
- ha quedado demostrada la eficacia neuroprotectora que permite ralentizar el avance de la enfermedad
Por ello el fabricante piensa enviar la documentación a las autoridades médicas de EEUU y UE para ser el primer medicamento en recibir la calificación de "efectivo contra la enfermedad" y no solo como paliativo de los síntomas
Creo que es una buena noticia