Povzetek glavnih značilnosti zdravila Aimovig (SmPC) (PDF)

Aimovig® (erenumab)

Zdravilo Aimovig® (erenumab) je indicirano za profilakso migrene pri odraslih, ki imajo najmanj 4 migrenske dni na mesec.¹
 

Prvo in edino popolnoma humano monoklonsko protitelo, ki se ciljano in z visoko afiniteto veže na receptor za CGRP.^{2, 3}
 

• Z dolgoročnimi dokazi, za manj migrenskih dni.⁶

• Vrednotenje varnostnega profila je trajalo do 5 let: najdaljša študija zdravila anti-CGRP.⁶

• Profil varnosti in prenosljivosti je podoben kot pri placebu.^4,5,6

• Enostavno odmerjanje enkrat na 4 tedne.¹

• 35,5 % bolnikov z epizodno migreno je bilo po 5 letih povsem brez migrenskih napadov.⁶

Reference:

1. Povzetek glavnih značilnosti zdravila Aimovig®. Junij 2023.

2. Shi L, Lehto SG, Zhu DXD et al. Pharmacologic Characterization of AMG 334, a Potent and Selective Human Monoclonal Antibody against the Calcitonin Gene-Related Peptide Receptor. J Pharmacol Exp Ther 2016; 356:223–231.

3. Russo AF. Calcitonin Gene-Related Peptide (CGRP): A New Target for Migraine. Annu. Rev. Pharmacol. Toxicol 2015. 55:533–52.

4. Goadsby PJ, Reuter U, Hallstrom Y, et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123-2132.

5. Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425-434.

6. Ashina M et al. Long-term effi cacy and safety of erenumab in migraine prevention: results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021. doi: 10.1111/ene.14715.

7. Novartis Fourth Quarter and Full year 2020 Condensed interim financial report – Supplementary Data.

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