GSK, Innoviva announce US nod for Trelegy Ellipta

GlaxoSmithKline and Innoviva have bagged a green light in the US for the novel triple therapy inhaler Trelegy Ellipta, opening the door to a new treatment option for patients with Chronic Obstructive Pulmonary Disorder (COPD).

Trelegy Ellipta combines three active molecules – fluticasone furoate, umeclidinium, vilanterol (FF/UMEC/VI), found in Breo Ellipta and Incruse Ellipta – in the same inhaler, and is the first once-daily triple medicine for COPD to hit the market.

It is also the first time a combination of an inhaled corticosteroid (ICS), long-acting beta2-adrenergic agonist (LABA) and long-acting muscarinic antagonist – three commonly use classes of medicine for respiratory conditions – has been approved for use in a single inhaler.

This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta.

The decision follows a recent marketing recommendation by the European Medicines Agency’s CHMP, based on data from the FULFIL study showing statistically significant improvements with the triple therapy compared with the dual therapy Symbicort Turbohaler (budesonide/formoterol) in both lung function, as measured by trough FEV1 (+171 mL), and health-related quality of life.

The study showed a statistically significant and clinically meaningful reduction in the annual rate of moderate/severe exacerbations with FF/UMEC/VI compared to Symbicort Turbohaler, with closed triple therapy showing a 35 percent reduction based on data up to 24 weeks and a 44 percent reduction in the subset of patients that received treatment for up to 52 weeks.

COPD is a common but serious lung disease that is thought to affect 384 million people worldwide.

PharmaTrendz-468×60
drug testing current affairs,drug testing jobs,drug testing news,drug testing news usa,drug testing openings,drug testing recruitment,drug testing talks,
    alembic pharma baroda,https://yandex ru/clck/jsredir?from=yandex ru;search;web;;&text=&etext=1824 4T7F3o0TjA8TyeVlKAWRvTxQhGZftRIGzaULiuXUSiUwUsPuCNE08-IcKJToD5TX 599282fee5cabd447a1e013ef4456b7022bcaadf&uuid=&state=_BLhILn4SxNIvvL0W45KSic66uCIg23qh8iRG98qeIXme,alembic of vadodara g,https://yandex ru/clck/jsredir?from=yandex ru;search;web;;&text=&etext=1821 yU_dXga9JsXcammzUZqGvHDXnTbZ1Az02YiKsp9bloh3lUVrS2RPnIJqwTpudrvk 9cf707f8f91249ac64f0049db03483e11f2afab2&uuid=&state=_BLhILn4SxNIvvL0W45KSic66uCIg23qh8iRG98qeIXme,storeciy,heartsrz,https://yandex ru/clck/jsredir?from=yandex ru;search;web;;&text=&etext=1823 kMgRosWxQBdxKRW5rTjR64vLyciIMGKSaHb0fPkirOIi6TyQzt_RycwMoEzN2dES a36e3ae7dbead4a83e251ef5801c4bbab31b018f&uuid=&state=_BLhILn4SxNIvvL0W45KSic66uCIg23qh8iRG98qeIXme,H4K6,https://yandex ru/clck/jsredir?from=yandex ru;search;web;;&text=&etext=1820 bzLoJkEaHpwmPZ2NTJfonwKzMWo_exMZlmxSSqF98d67w2JJwjfB7PJM_JtQ26lt 437052969596cdadde56363d95aa503866f59ed6&uuid=&state=_BLhILn4SxNIvvL0W45KSic66uCIg23qh8iRG98qeIXme,decidehis