Eleven therapies put forward to the EMA for EU approval

EMAEleven new medicines have been put forward for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use, including new options for a rare eye disease, schizophrenia and cartilage defects.

Oxervate won backing as a treatment for moderate or severe neurotrophic keratitis, a rare eye disease that can lead to loss of sight.

According to the Agency, there is currently no satisfactory treatment for the condition. Oxervate is a replica of a human growth factor called nerve growth factor that is expected to help restore some of the normal healing processes in the eye and repair damage to the cornea.

A marketing authorisation is also being recommended for a new advanced therapy medicinal product, spherox, that treats adult patients who have symptomatic articular cartilage defects in the femoral condyle (the ball-shaped end of the thigh bone in the knee) and the patella (knee cap), where the size of the affected area is no larger than 10 cm².

Damage to the articular cartilage of the knee is often found as a common orthopaedic problem in young, active people for a number of reasons.

Spherox is composed of spheroids – spherical aggregates of chondrocytes (cells that are found in healthy cartilage). The therapy involves removing a small piece of healthy cartilage from which chrondrocyte spheroids are then produced in a laboratory. These are then inserted arthroscopically in the patient’s knee where they form new tissue to heal the defect.

The Committee for Medicinal Products for Human Use (CHMP) also backed approval for:

•    Gedeon Richter’s Reagila for schizophrenia. The drug has been found to improve psychotic symptoms, its most common side effects are akathisia and parkinsonism;

•    LEO Pharma’s treatment for moderate to severe forms of plaque psoriasis, Kyntheum. The treatment inhibits the inflammation and clinical symptoms associated with the condition. The most common side effects are arthralgia, headache, fatigue, diarrhoea, and oropharyngeal pain;

•    Chiesi Farmaceutici’s Trimbow for the maintenance treatment of moderate to severe COPD. The EMA says the benefits of the drug are its ability to relieve and prevent symptoms such as shortness of breath, wheezing and cough and to reduce exacerbations of COPD symptoms. Side effects of the treatment include oral candidiasis, muscle spasm and dry mouth;

•    Vifor Fresenius Medical Care Renal Pharma France’s Veltassa for the treatment of hyperkalaemia. The drug lowers serum potassium levels. The most commonly reported adverse events are hypomagnesaemia, constipation, diarrhoea, abdominal pain and flatulence.

Four biosimilars were also suggested for approval by the Agency: sanofi-aventis’ Insulin lispro for diabetes mellitus; and three from Celltrion Healthcare Hungary with rituximab as their active substance – Blitzima and Tuxella, for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia (CLL), granulomatosis with polyangiitis and microscopic polyangiitis, and Ritemvia for the same conditions except for CLL .

Furthermore a generic medicine received a positive opinion from the CHMP: Efavirenz/Emtricitabine/Renofovir disoproxil Zentiva for the treatment of HIV infection.

However, applications were rejected for: Helsinn Birex’ Adlumiz (anamorelin hydrochloride) as a treatment for anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer; XBiotech’ Human IgG1 monoclonal antibody specific for human interleukin-1 alpha for debilitating symptoms of advanced colorectal cancer; and AB Science’s Masipro (masitinib) for systemic mastocytosis.


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