Innoviva Inc (NASDAQ:INVA) and GlaxoSmithKline plc (ADR) (NYSE:GSK) today made the much awaited announcement. The two business giants have made a submission to the European Medicines Agency (EMA.
They hope to obtain the go-ahead for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI).This happens to be an inhaled corticosteroid (ICS) / long-acting β2-agonist (LABA) combination provided to those persons controlled on an ICS/LABA combination.
While addressing a recent board meeting, the company’s CEO said, “FF/VI is currently indicated in Europe for the regular treatment of patients aged 12 and over with asthma who are not adequately controlled on both ICS and ‘as-needed’ short-acting β2-agonist (SABA) and where use of a combination product (ICS and LABA) is appropriate. The proposed indication would also include those patients already adequately controlled on an ICS/LABA combination.”
This particular submission covers critical positive data obtained from a recent reported1 non-inferiority lung function study which brought out a crucial medical revelation. It outlined that those patients with well-controlled asthma are in a position to switch from twice-daily fluticasone propionate/salmeterol, FP/SAL (Seretide Accuhaler) 250/50 to once-daily FF/VI 100/25.This of course happens smoothly without compromising the functions of their lungs in any way.
The data emanating from this study (201378) has been brought into close review by some top experts. From their reports, the adverse event data showed a lot of consistency with the known safety profile for FF/VI identified in those persons that had been struggling with Asthma. Asides from this, the experts did not see any new safety signals. The European regulatory authorities contributed in coming up with the study design and the future looks bright.
While recently addressing some top journalists, one of the provider’s top officials working with GlaxoSmithKline said that they were indeed happy with their progress lately He stated that it was great working closely with a co-operative partner like Innoviva Inc and they hoped to achieve much more together.
The competition in the world markets is stiff now more than ever. Some people attribute it to the technological advancements sweeping across. The two companies hope to improve their rankings in the industry according to Yahoo.