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Dix nouveaux médicaments sur le marché pharmaceutique.

  • 18 mai 2017

  • Par : A. Oussama

  • Tags : ANSM, AMM

Dans un point d’information, l’ANSM rapporte que le comité des médicaments à usage humain (CHMP) de l’Agence européenne des médicaments (EMA) a rendu dix (10) avis favorables pour de nouvelles autorisations de mise sur le marché (AMM).

Les nouvelles AMM sont :

  1. Besponsa (inotuzumab ozogamicin) dans le traitement de seconde ligne de la leucémie aiguë lymphoblastique.  Besponsa a une désignation de médicament orphelin.
  2. Kevzara (sarilumab) dans le traitement de la polyarthrite rhumatoïde.
  3. Skilarence  (dimethyl fumarate) dans le traitement du psoriasis.
  4. Cuprior  (trientine tetrahydrochloride) dans le traitement de la maladie de Wilson, une affection rare autosomale récessive. Cuprior a une désignation de médicament orphelin .
  5. Spinraza  (nusinersen) dans le traitement de l’amyotrophie spinale.
  6. Brineura  (cerliponase alfa) dans le traitement de la céroïde-lipofuscinose neuronale de type 2 (CLN2).
  7. Erelzi  (etanercept) dans le traitement de la polyarthrite rhumatoïde, de l’arthrite juvénile idiopathique, du rhumatisme psoriasique, de la spondylarthrite ankylosante, du psoriasis en plaques et du psoriasis en plaques infantile. Erelzi est un médicament biosimilaire de la spécialité de référence Enbrel.
  8. Rixathon  (rituximab) et Riximyo (rituximab) dans le traitement du lymphome non hodgkinien, de la polyarthrite rhumatoïde, de la granulomatose avec polyangéite, de la polyangéite microscopique et de la leucémie lymphoïde chronique. Rixathon et Riximyo sont deux médicaments biosimilaires de la spécialité de référence Mabthera.
  9. Febuxostat Mylan (febuxostat) dans la prévention et le traitement de l’hyperuricémie.
  10. Ucedane  (acide carglumic) dans le traitement de l’hyperammoniémie due à un déficit primaire en N-acetylglutamate synthase.

Sources : ANSM