Trelegy Ellipta is approved as a maintenance treatment for COPD and asthma in the US. Image Credit: MAXSHOT.PL / Shutterstock.
Singapore’s Health Sciences Authority (HSA) has expanded the label of GlaxoSmithKline (GSK)’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include its use as a maintenance therapy for adults with asthma.
The Singapore agency also approved a new dosage strength for the inhaled therapy in asthma. In 2019, HSA approved Trelegy Ellipta as a maintenance therapy for relieving moderate to severe exacerbations in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is approved as a
maintenance treatment for COPD
in multiple regions including the US, Europe and China. However, the drug has also been
approved for treating asthma in a few countries
such as the US.
Trelegy Ellipta pulled in £2.2bn ($2.8bn) in global sales for GSK in 2023, as per the company’s financials. The drug sales are expected to rise, with Trelegy Ellipta expected to generate approximately $3.8bn in global sales in 2027, according to a GlobalData analysis.
GlobalData is the parent company of
Pharmaceutical Technology
.
Last month, GSK announced plans to cap out-of-pocket costs for eligible patients at $35 per month for its COPD and asthma medications in light of the
rising drug prices
in the US. Trelegy Ellipta is one of the drugs included in GSK’s programme, which will be implemented across the country no later than 1 January 2025.
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Another therapy looking to target both asthma and COPD populations is
Amgen
and
AstraZeneca
’s Tezspire (tezepelumab-ekko). The monoclonal antibody has been
approved for treating severe asthma
in multiple countries including the US. The companies are evaluating the therapy in patients with moderate to severe COPD in a placebo-controlled Phase II trial (NCT04039113). Data from the trial is expected in H1 this year.
Regeneron Pharmaceuticals
and
Sanofi
are also
seeking approval for their monoclonal antibody
, Dupixent (dupilumab) as a maintenance therapy for COPD. The US Food and Drug Administration (FDA) has set a target action date of 27 June for an approval decision. Dupixent is approved for treating
atopic dermatitis
, asthma, chronic rhinosinusitis with nasal polyposis,
eosinophilic esophagitis
and prurigo nodularis.