European Medicines Agency
EMA recommends seven new medicines for approval
Committee discussed drugs for diabetes, infertility, Duchenne muscular dystrophy and other metabolic diseases.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended seven medicines for approval, including one biosimilar and one orphan medicine, at its most recent meeting held on 22–25 January 2018.
The CHMP also gave positive opinions for three medicines to treat type 2 diabetes including, ertugliflozin/metformin (Segluromet; Merck Sharpe & Dohm Limited), ertugliflozin (Steglatro; Merck Sharpe & Dohm Limited), and ertugliflozin/sitagliptin (Steglujan; Merck Sharpe & Dohm Limited).
One of the medicines recommended by the CHMP for marketing authorisation was the “first-in-class” medicine, emicizumab (Hemlibra; Roche), used to prevent bleeding episodes in patients with haemophilia A who have factor VIII inhibitors. Due to the importance of the medicine to public health, it was reviewed under the EMA’s accelerated assessment procedure.
The CHMP also recommended a recombinant, adjuvanted herpes zoster vaccine (Shingrix; GSK Biologicals) for the prevention of herpes zoster and post-herpetic neuralgia in adults aged 50 years or older; and confirmed its previous positive opinion for sodium zirconium cyclosilicate (Lokelma; AstraZeneca AB), a drug for hyperkalaemia.
The biosimilar recommended by the Committee was insulin glargine (Semglee; Mylan S.A.S), for the treatment of diabetes.
The recommended orphan medicine was velmanase alfa (Lamzede; Chiesi Farmaceutici S.p.A.), a long-term enzyme replacement therapy for adults, adolescents and children with mild to moderate forms of alpha-mannosidosis, a rare inherited disorder that causes problems in many organs and tissues of the body.
During the meeting the CHMP adopted a negative opinion for enclomifene (EnCyzix; Renable Pharma Ltd.) recommending the refusal of the marketing authorisation of the drug for the treatment of hypogonadotrophic hypogonadism in overweight men. Hypogonadotrophic hypogonadism is condition where the sex organs do not work properly resulting in symptoms such as infertility and impotence.
The CHMP’s main concerns about the drug were based on that fact that although studies showed that enclomifene increased testosterone levels, they did not look at whether it improved the symptoms of hypogonadotrophic hypogonadism. In addition, the CHMP highlighted that the drug was linked to venous thromboembolism.
A requested re-examination of the Committee’s negative opinion of idebenone (Raxone, Santhera Pharmaceuticals GmbH), which was intended for an additional use in patients with Duchenne muscular dystrophy to slow their gradual loss of breathing ability, was also discussed at the meeting.
The CHMP decided to confirm the refusal of the change to the marketing authorisation due to concerns about the way the study was conducted and analysed and the conclusion that the benefits of idebenone did not outweigh its risks.
The Committee also recommended extensions of indications for three drugs: human normal immunoglobulin (Hizentra; CSL Behring GmbH), for the treatment of patients with chronic inflammatory demyelinating polyneuropathy as maintenance therapy after stabilisation with IVIg; and fluticasone furoate/vilanterol (Relvar Ellipta/Revinty Ellipta; Glaxo Group Ltd) for the regular treatment of asthma in adults and adolescents aged 12 years and older already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonists.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204318
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