New drugsThe European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended nine new medicine receive marketing authorisation at its December meeting.

The medicines which received marketing authorisation include:

  • Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC). The Committee reviewed Tagrisso under EMA’s accelerated assessment program. Conditional approval and accelerated assessment are two of the Agency’s main mechanisms to facilitate earlier access by patients to medicines that fulfil unmet medical needs
  • Portazza (necitumumab), also for the treatment of NSCLC
  • Neofordex (dexamethasone), a medicine with an orphan designation, for the treatment of symptomatic multiple myeloma. Neofordex was submitted as a hybrid application. This type of application relies in part on the results of studies carried out with a reference product and in part on new data
  • Feraccru (ferric maltol) for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease
  • Zurampic (lesinurad) received a positive opinion from the Committee for the treatment of hyperuricaemia (an excess of uric acid in the blood)
  • Vaxelis, a vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B
  • Iblias and Kovaltry (octocog alfa) received positive opinions for the treatment and prophylaxis of bleeding in patients with haemophilia A. These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorisation applications of both medicines
  • Caspofungin Accord (caspofungin), a generic medicine, received a positive opinion from the Committee for the treatment of fungal infections.

However, negative opinions were expressed for Dropcys (mercaptamine hydrochloride), which was intended to prevent and treat cystinosis affecting the eye. For more information, please see the questions-and-answers document in the grid below.

For more information click here