Industry News: GSK’s Second Salford-Lung Study, Data from Novartis, and How to Approach Real-World Studies

Keeping up with news from across the industry can be a bit of a headache. There are new studies coming out every day and new initiatives launching all the time. Don’t stress. We’ve neatly chunked together 3 of the most interesting stories from the last month – so you don’t have to! This month we see data from Real-World studies published by GSK and Novartis. We also hear from Dr Martin Goldman who gives a run down of the different types of Real-World methodologies that we will see creeping into practice more often over the coming months and years.

GSK’s inhaler improves asthma control in ‘real world’ study
By Selina McKee for Pharma Times

GlaxoSmithKline and Innoviva have unveiled data from a second ground-breaking Salford Lung Study (SLS). Data showed that Relvar Ellipta significantly improved asthma control versus patients’ standard therapy. Patients initiated with Relvar Ellipta (fluticasone furoate/FF and vilanterol/VI) had twice the odds of achieving an improvement in asthma control than those continuing with their usual care, which included inhaled corticosteroids (ICS) administered as monotherapy or as ICS/LABA (long acting beta agonist) combinations.

Real-world evidence: It’s all in the approach
By Dr Martin Goldman for PMLive

We know that the controlled clinical trial is no longer the exclusive provider of data to support the authorisation, marketing and reimbursement of a medicinal product. Even the European Medicine Agency (EMA) has taken a position accepting that there is value and merit in real-world evidence, and in a recent expert group report, the EMA and the EC point out the uses of such data in supporting pharmacovigilance, comparative efficacy and pricing negotiations for new treatments.

Novartis real-world data at AAN confirms benefit of Gilenya on four key measures of disease activity in relapsing MS
GlobeNewswire

Novartis announced data from the Phase IV Multiple Sclerosis and clinical outcome and MRI in the US (MS-MRIUS) study. The data confirmed the effectiveness of Gilenya^® (fingolimod) in the real-world setting, supporting previous findings from Phase III trials. Results show that Gilenya impacted four key measures of MS disease activity (relapses, MRI lesions, disability progression and brain shrinkage), in people with relapsing-remitting multiple sclerosis (RRMS) for up to 16 months. In addition, this is the first time a multicenter study has evaluated and shown that routine magnetic resonance imaging (MRI) scans taken in the every-day clinical setting can reliably be used to measure brain shrinkage, a key measure of disease progression, in people with RRMS.