Eleven medicines recommended for approval, including one advanced therapy medicine
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines, including one advanced therapy medicinal product (ATMP), for approval at its May 2017 meeting.
The CHMP recommended granting a marketing authorisation for the ATMP Spherox (spheroids of human autologous matrix-associated chondrocytes) to treat adult patients who have symptomatic articular cartilage defects in the knee where the size of the affected area is no larger than 10 cm².
The CHMP recommended granting a marketing authorisation for Oxervate (cenegermin) for the treatment of moderate to severe neurotrophic keratitis. Oxervate has an orphan designation.
Reagila (cariprazine) received a positive opinion from the Committee for the treatment of schizophrenia.
The CHMP granted a positive opinion for Kyntheum (brodalumab) for the treatment of moderate to severe plaque psoriasis.
Trimbow (beclometasone / formoterol / glycopyrronium bromide) received a positive opinion for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).
Veltassa (patiromer) received a positive opinion for the treatment of hyperkalaemia.
Four biosimilar medicines were recommended for approval by the Committee: Insulin lispro Sanofi (insulin lispro) received a positive opinion for the treatment of diabetes mellitus. Three medicines with rituximab as their active substance received a positive opinion: Blitzima and Tuxella, for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, granulomatosis with polyangiitis and microscopic polyangiitis; and Ritemvia, for the treatment of non-Hodgkin’s lymphoma, granulomatosis with polyangiitis and microscopic polyangiitis.
A biosimilar medicine is a biological medicine that is highly similar to another biological medicine already authorised for use.
One generic medicine received a positive opinion from the CHMP: Efavirenz / Emtricitabine / Tenofovir disoproxil Zentiva (efavirenz / emtricitabine / tenofovir disoproxil) for the treatment of HIV infection.
Negative opinions on three new medicines
The CHMP adopted a negative opinion for Adlumiz (anamorelin hydrochloride). Adlumiz was expected to be used to treat anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer.
The Committee adopted a negative opinion for Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech. This medicine was intended to treat debilitating symptoms of advanced colorectal cancer.
The Committee also adopted a negative opinion for Masipro (masitinib). Masipro was intended to be used to treat systemic mastocytosis.
Six recommendations on extensions of therapeutic indications
The Committee recommended extensions of indications for Izba, Komboglyze, Onglyza, Renvela, Sevelamer carbonate Zentiva and Zykadia.
Withdrawal of application
An application for an initial marketing authorisation for Qinprezo (vosaroxin) has been withdrawn. This medicine was intended to be used in combination with the cancer medicine cytarabine for the treatment of acute myeloid leukaemia.
Outcome of review on vancomycin antibiotics
The CHMP has recommended changes to the prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria.