HOT & NOT

The European Commission (EC) has approved Roche’s oral treatment Xofluza (baloxavir marboxil) for the treatment of influenza, making it the first new antiviral available for flu in nearly 20 years. The single-dose, oral medicine is now available in the EU as a treatment for uncomplicated influenza in patients aged 12 years and above, as well as for post-exposure prophylaxis of influenza in the same age groups, after showing in trials that it cut the duration of symptoms by over one day versus placebo.

ViiV Healthcare has bagged EU approval for a dispersible tablet form of its HIV-1 therapy Tivicay (dolutegravir) in paediatric patients aged at least four weeks and weighing at least 3kg. The move makes Tivicay the first integrase inhibitor available as a dispersible tablet for this population, enabling children to have access to age-appropriate formulations of HIV medicine. Globally around 1.7 million children live with HIV and around 100,000 children die each year from AIDS, highlighting a significant unmet medical need.

Diurnal has submitted a marketing authorisation application for Chronocort (modified-release hydrocortisone) to the UK’s MHRA for patients with the rare condition congenital adrenal hyperplasia (CAH). The submission is based on the same application to the European Medicines Agency (EMA), made in December 2019, on which Diurnal is expecting a decision in the first quarter of 2021. The company said it is also seeking British Orphan Drug Status for Chronocort in CAH.

NICE has turned down Bristol Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum-based chemotherapy. In draft guidance, NICE said evidence collected in the clinical trial and through its own CDF showed that people with SCCHN live longer when treated with Opdivo than with one of three possible treatments in the comparator arm, but that there remained uncertainty around these results and the overall survival benefit.

AstraZeneca and Amgen have announced that a Phase III trial of their new medicine tezepelumab failed to meet the primary endpoint in patients with severe, oral corticosteroid-dependent asthma. The SOURCE trial failed to meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroids dose, without loss of asthma control, with tezepelumab compared to placebo. However, the drug’s effect on other measures of efficacy was similar to those observed in previous trials, AZ said in a statement.

The Scottish Medicines Consortium is not recommending NHS funding for Flynn Pharma's Slenyto (melatonin) for the treatment of insomnia in children with autism spectrum disorder and/or Smith-Magenis syndrome (a rare neurogenetic disorder). While the drug increased total sleep time and sleep onset latency in children aged two to 17.5 years in the target patient population, the company did not present a sufficiently robust economic analysis to satisfy the committee that it offers value for money to NHS Scotland.