Six new medicines, including the first hormone replacement therapy for a thyroid disorder, have been put forward for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use.
Orphan medicine Natpar (parathyroid hormone) has been recommended by the Committee for conditional marketing authorisation as a treatment for patients with chronic hypoparathyroidism who cannot be adequately controlled with standard treatment with calcium and vitamin D.
Hypoparathyroidism is a hormone disorder where the parathyroid glands in the neck produce too little parathyroid hormone. This results in too little calcium and too much phosphate in the blood, which affects the normal functioning of nerves and muscles and leads to symptoms such as tingling sensations and muscle spasms or even seizures and heart rhythm disorders. There are currently no treatment options for the condition.
Natpar is a once-daily injection identical to human parathyroid hormone, replacing to some extent the missing hormone in patients with hypoparathyroidism and thus helping to restore calcium and phosphate levels in patients where standard therapy with calcium and vitamin D is insufficient or poorly tolerated.
The Committee also backed approval of AstraZeneca's ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia, a serious condition characterised by high potassium levels in the blood serum caused by cardiovascular, renal and metabolic diseases.
Sodium zirconium cyclosilicate selectively binds potassium in exchange for hydrogen and sodium cations throughout the gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen, which lowers serum potassium levels by drawing potassium into the GI tract and increasing faecal potassium excretion to resolve the condition.
According to the CHMP, the most common side effects linked with the drug are hypokalaemia and oedema related events.
Tesaro UK's Varuby (rolapitant) was recommended for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.
Higlighting the need for a new treatment option for the condition, Mary Lynne Hedley, president and chief operating officer of Tesaro, noted that more than half of patients treated with emetogenic chemotherapy experiencing this debilitating side effect for up to five days.
The Committee said the drug's benefits are its ability to reduce emetic episodes and the use of rescue medicines in the delayed phase (after 24 to 120 hours) in patients treated with highly or moderately emetogenic chemotherapy, while the most common side effects are headache, constipation and fatigue.
A positive opinion was also handed down for Daiichi Sankyo Europe's informed consent application for Roteas (edoxaban) for the prevention of stroke and systemic embolism in adults with atrial fibrillation, and for the treatment and prevention of deep vein thrombosis and pulmonary embolism.
The Committee concluded the drug can reduce the combined risk of stroke and systemic embolic events in patients with nonvalvular atrial fibrillation who are at risk of stroke and systemic embolic events, and treat and reduce the risk of recurrence of symptomatic venous thromboembolism in patients who had acute symptomatic deep vein thrombosis and/or pulmonary embolism.
The most common side effects are cutaneous soft tissue haemorrhage (up to 5.9 percent), epistaxis (up to 4.7 percent) and vaginal haemorrhage, but bleeding can occur at any site and may be severe and even fatal, the regulator noted, adding that other common adverse reactions for edoxaban are anaemia, rash and abnormal liver function tests.
Elsewhere, two generic medicines were backed: Emtricitabine/Tenofovir disoproxil Krka d.d. (emtricitabine/tenofovir disoproxil) for the treatment of HIV infection; and Pemetrexed Hospira UK (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.