Six medicines have taken a giant leap closer to European approval after being endorsed by the Committee for Medicinal Products for Human Use.
First up, Bristol-Myers Squibb’s immunotherapy Empliciti (elotuzumab) has been recommended after an accelerated review as a treatment for the generally incurable blood cancer multiple myeloma.
The drug should be used in combination with lenalidomide (Celgene’s Revlimid) and the anti-inflammatory medicine dexamethasone for the treatment of patients who have received at least one prior therapy.
The CHMP’s recommendation is based on Phase III data showing that in patients taking Empliciti as well as lenalidomide/dexamethasone the disease progressed more slowly (difference in medians of 4.2 months) than in those taking the latter regimen alone.
In addition, 78.5% of patients taking Empliciti with lenalidomide/dexamethasone saw a complete or partial shrinkage of their tumours compared to 65.5% of those in the lenalidomide/dexamethasone arm.
The most common side effects of the drug were found to be infusion-related reactions, diarrhoea, cough, herpes zoster, nasopharyngitis, pneumonia, upper respiratory tract infection, lymphopenia and weight loss.
A marketing authorisation was also recommended for Bio Products’ Coagadex (human coagulation factor X), potentially the first specific replacement therapy to treat the rare and inherited bleeding disorder factor X deficiency.
Coagadex is indicated for the treatment and preventive management of bleeding episodes and the control of bleeding during surgical procedures in patients with hereditary factor X deficiency.
A Phase III study evaluated the treatment of a total of 207 spontaneous bleeds in 16 patients with moderate or severe factor X deficiency and demonstrated an effective response (excellent or good in 98.8% of the bleeds treated).
Elsewhere, Actelion’s orphan drug Uptravi (selexipag) was put forward for the treatment of pulmonary arterial hypertension (PAH).
PAH is a progressive disease caused by the narrowing or tightening of the pulmonary arteries around the heart, causing symptoms such as breathlessness, fatigue, weakness and angina. While options are available to address these symptoms there is currently no treatment that slows progression or cures the disease, and fewer than 40% of patients live beyond five years of diagnosis.
According to the Phase III GRIPHON study, Uptravi decreased the risk of a morbidity/mortality event versus placebo by 40% with efficacy consistent across different subgroups (gender, age, etc).
Three generic medicines by Mylan also received CHMP backing: Amlodipine-Valsartan Mylan (amlodipine/valsartan) for the treatment of essential hypertension; Rasagiline Mylan (rasagiline) for the treatment of idiopathic Parkinson’s disease; and Zonisamide Mylan (zonisamide) for the treatment of partial seizures, with or without secondary generalisation.