The Committee for Medicinal Products for Human Use (CHMP) has recommended 10 medicines for use, following its June meeting.
The medicines approved include two enzyme replacement therapies for the treatment of rare genetic diseases – sebelipase alfa for the treatment of lysosomal acid lipase deficiency, and asfotase alfa for the bone disease hypophosphatasia that started in childhood. Both have an orphan designation.
The CHMP also recommended granting a marketing authorisation for panobinostat for the treatment of relapsed and/or refractory multiple myeloma. panobinostat is the first cancer medicine that targets enzymes known as histone deacetylases. It too has an orphan designation.
- Sonidegib received a position opinion for the treatment of basal cell carcinoma.
- Respreeza (human alpha1-proteinase inhibitor) was recommended for the treatment of alpha1-proteinase inhibitor deficiency
- Three generic medicines received positive opinions from the CHMP – docetaxel for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer, duloxetine for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder, andpregabalin for the treatment of epilepsy and generalised anxiety disorder.
- Two ‘hybrid’ medicines received positive opinions from the Committee – aripiprazole for the treatment of schizophrenia and the prevention and treatment of manic episodes in bipolar 1 disorder, and idebenone for the treatment of visual impairment in patients with Leber’s hereditary optic neuropathy.