EMA recommends five drugs for approval after December meeting
Posted: 16 December 2019 | Victoria Rees (European Pharmaceutical Review) | No comments yet
The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has released its recommendations from its December meeting.
The CHMP has endorsed five medicines for approval:
- Beovu (brolucizumab) – for the treatment of neovascular age-related macular degeneration, which affects the central part of the retina and causes a loss of vision
- Recarbrio (imipenem/cilastatin/relebactam) – for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options
- Amsparity (adalimumab) – a biosimilar for the treatment of certain inflammatory and autoimmune disorders
- Azacitidine Accord (azacitidine) – a generic for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia
- Dexmedetomidine Accord (dexmedetomidine) – a generic for the induction of light to moderate sedation of adults in an intensive care unit.
Akynzeo, Cyramza, Darzalex, Dificlir, Erleada, Sirturo, Stelara and Vyndaqel were all recommended by the CHMP for an extension of therapeutic indication.
Related topics
Drug Markets, QA/QC, Regulation & Legislation, Research & Development (R&D)
Related organisations
Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA)
Related drugs
Akynzeo, Amsparity (adalimumab), Azacitidine Accord (azacitidine), Beovu (brolucizumab), Cyramza, Darzalex, Dexmedetomidine Accord (dexmedetomidine), Dificlir, Erleada, Recarbrio (imipenem/cilastatin/relebactam), Sirturo, Stelara, Vyndaqel
Related diseases & conditions
acute myeloid leukaemia, autoimmune disorders, chronic myelomonocytic leukaemia, Macular degeneration, myelodysplastic syndrome
