dm+d

34955711000001102

New Medicines

Trelegy ElliptaAsthma in adults inadequately controlled with dual steroid/beta agonist therapy

Information

Trelegy Ellipta
Licence extension / variation
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Phase III Clinical Trials
Not recommended for approval (Negative opinion)
Launched
Apr 22Company plans to seek a licence in the UK [12].
Sep 21Development outside the US has been discontinued [11].
Feb 21GSK had applied for an extension of the approved EU indication to add the maintenance treatment in adult patients with asthma whose symptoms could not be controlled well enough with a combination of inhaled corticosteroid and a long-acting beta-2 agonist [10].
Feb 21CHMP has recommended refusal of the change to marketing authorisation (Negative opinion). The Committee considered that an improvement in lung function alone is not enough to show that a medicine is suitable for treating asthma. The main study did not clearly show that the medicine was effective at reducing asthma attacks or controlling symptoms. Therefore the benefits were not considered to outweigh the risks. The company may appeal this decision and ask for a re-examination of the opinion within 15 days, but cannot present new data at this stage [10].
Sep 20Approved in US [9].
Feb 20Filed in EU [7].
Oct 19Filed in US [5].

Category

Inhaled corticosteroid/LAMA/LABA combination therapy in Ellipta(R) dry powder device
Asthma is common in UK, around 5.4 million people in the UK receive treatment [2].
Asthma in adults inadequately controlled with dual steroid/beta agonist therapy
Inhalation

Trial or other data

Sep 20PIII CAPTAIN (n=2439) found that in patients with inadequately controlled asthma despite being on ICS/LABA, adding UMEC improved lung function but did not lead to significant reduction in moderate and/or severe exacerbations [8].
May 19PIII CAPTAIN study (NCT02924688 ) in patients with asthma meets primary endpoint. Study demonstrated statistically significant 110mL improvement in lung function (change from baseline in trough FEV1 at 24 weeks) for FF/UMEC/VI 100/62.5/25mcg(p<0.001) vs. Relvar/Breo 100/25mcg and 92mL improvement for FF/UMEC/VI 200/62.5/25mcg vs. Relvar/Breo 200/25mcg(p<0.001) [4].
Oct 18PIII (NCT02924688) is active, not recruiting. Collection of primary outcome should now complete Feb 19 [3].
Jul 18PIII (NCT03184987)is a study to evaluate the long-term safety of fluticasone furoate/umeclidinium/vilanterol, in Japanese patients with asthma . The 52-week, open label study is expected to enrol 111 subjects in Japan and collection of the primary outcome is expected in Jun 19 [3].
Dec 16PIII randomized, double-blind, multicenter study starts, comparing FF/UMEC/VI (100/31.25/25, 100/62.5/25, 200/31.25/25 or 200/62.5/25 micrograms) versus FF/VI (100/25 or 200/25 micrograms), once daily in the morning in patients with inadequately controlled asthma on maintenance treatment. The study aims to randomize 375 patients to each treatment arm [1].

Evidence based evaluations