CHMP News – June 2015


CHMP recommended ten new medicines for approval

At its June 2015 meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended ten new medicines for approval

The CHMP recommended the following medicines:

  • two enzyme replacement therapies for the treatment of rare genetic diseases, both of which have an orphan designation: Kanuma (sebelipase alfa) for the treatment of lysosomal acid lipase deficiency, and Strensiq (asfotase alfa), the first therapy for the bone disease hypophosphatasia that started in childhood.
  • Farydak (panobinostat) for the treatment of relapsed and/or refractory multiple myeloma that is the first cancer medicine that targets enzymes known as histone deacetylases and that also has an orphan designation.
  • Odonzo (sonidegib) for the treatment of basal cell carcinoma.
  • Respreeza (human alpha1-proteinase inhibitor) for the treatment of alpha1-proteinase inhibitor deficiency;
  • three generic medicine - Docetaxel Hospira UK Limited for the treatment of breast cancer , non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer; Duloxetine Zentiva (duloxetine) for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder and Pregabalin Accord (pregabalin) for the treatment of epilepsy and generalised anxiety disorder.

Two "hybrid” medicines: Aripiprazole Sandoz (aripiprazole) for the treatment of schizophrenia and the prevention and treatment of manic episodes in bipolar I disorder, and Raxone (idebenone) for the treatment of visual impairment in patients with Leber’s hereditary optic neuropathy. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials carried out with the reference and in part on new data.

Negative opinion on new medicine

The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for the advanced therapy medicinal product Heparesc (human heterologous liver cells) that was intended to be used for the treatment of certain urea cycle disorders.

Four recommendations on extensions of therapeutic indication

The CHMP recommended extensions of indication for Humira, Levemir, Perjeta and Voncento.

Outcome of review on adrenaline auto-injectors

The CHMP recommended several measures, including the introduction of educational material, to ensure that patients and carers use adrenaline auto-injectors successfully. An adrenaline auto-injectors are potentially life-saving treatments for anaphylaxis (severe allergic reactions) while the patient waits for emergency medical assistance.

More information on the CHMP-June 2015 meeting is available on the EMA’s webpages, or here.