HOT & NOT

Amarin’s Vazkepa (icosapent ethyl) has received authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment to cut the risk of cardiovascular (CV) events in high-risk patients. The approval covers use of the drug in high CV risk statin-treated adult patients who have elevated triglycerides and either established CV disease or diabetes and at least one additional CV risk factor.

The European Commission has approved expanded use of GlaxoSmithKline’s intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for adults with active lupus nephritis (LN). The drug is already on the market to treat systemic lupus erythematosus (SLE); this latest approval now provides physicians and patients in Europe with the first and only biologic treatment specifically designed to work in lupus and LN.

Astellas' Xtandi (enzalutamide) has won approval for an additional indication from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA): as once-daily treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC). Xtandi is now the only oral treatment approved by the MHRA for three types of advanced prostate cancer, including high-risk non-metastatic and metastatic castration-resistant prostate cancer and mHSPC.

A gene therapy developed by Biogen for the eye disease X-linked retinitis pigmentosa (XLRP) failed to meet the primary goal of a Phase II/III study. The trial measured changes in retinal sensitivity after one year, to assess if cotoretigene toliparvovec could induce improvements from baseline. The therapy showed no significant improvement over the control group, but “positive trends” were observed across a number of secondary endpoints, the firm noted.

NICE has published draft guidance rejecting Janssen's Erleada (apalutamide) with androgen deprivation therapy (ADT) for treating prostate cancer. Trial results suggest that, compared with placebo plus ADT, Erleada plus ADT improves progression-free survival and survival. However, NICE considers the evidence is uncertain, and notes that in the trial some people could switch to other treatments, and some could receive treatments not available in the NHS.

Pfizer’s Vyndaqel (tafamidis) has been rejected by the UK National Institute for Health and Care Excellence (NICE) as a treatment for the rare heart condition transthyretin amyloidosis with cardiomyopathy (ATTR-CM), which affects around 800 people in the UK. NICE said that cost-effectiveness estimates for Vyndaqel – which is the first treatment to be approved for the condition – are higher than what would normally be considered an acceptable use of NHS resources.