Eleven 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 (cenegermin) has 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 copy of a human growth factor called nerve growth factor which 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 (ATMP) 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 a common orthopaedic problem which often occurs in young, active people for a variety 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 knee where they form new tissue to heal the defect.
Elsewhere, the CHMP backed approval for:
*Gedeon Richter’s Reagila (cariprazine) for schizophrenia. The drug can improve psychotic symptoms, its most common side effects are akathisia and parkinsonism;
*LEO Pharma’s Kyntheum (brodalumab) for the treatment of moderate to severe plaque psoriasis. Kyntheum 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 (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease (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 include oral candidiasis, muscle spasm and dry mouth; and
*Vifor Fresenius Medical Care Renal Pharma France’s Veltassa (patiromer) 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 put forward for approval by the Agency: sanofi-aventis’ Insulin lispro Sanofi (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 .
One generic medicine received a positive opinion from the CHMP: Efavirenz/Emtricitabine/Renofovir disoproxil Zentiva for the treatment of HIV infection.
On the downside, 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.