Fluticasone furoate

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. See Also: UK MHRA approves Advanz Pharma antibiotic for complex infections Japan’s PMDA approves Partner’s inhaled Leukine for aPAP 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.

Lupin Limited (Lupin) announced that it has launched the world’s first fixed-dose triple combination drug (FDC) under the brand name Vilfuro-G® for the effective management of chronic obstructive pulmonary disease (COPD) in India. This milestone follows the approval granted by the Drug Controller General of India for the Dry Powder Inhaler (DPI) product. Lupin Vilfuro-G® is the only FDC that uniquely combines Vilanterol, Fluticasone Furoate and Glycopyrronium Bromide, for the long-term management and treatment of moderate to severe COPD. The product is available in a single-strength fixed dose, with a recommended once-daily dosage. This therapeutic innovation by Lupin brings hope to more than 37 million individuals struggling with COPD in India, a condition that ranks among the leading causes of death and disability in the nation. Commenting on the launch, Nilesh Gupta, Managing Director, Lupin said, “We are delighted to introduce Vilfuro-G, a testament to our commitment to our patients and our focus on innovation. This milestone reinforces our resolve to expanding our respiratory portfolio, providing COPD patients with access to healthcare solutions, and transforming lives.” “As the global prevalence of COPD continues to surge, India bears a significant 18% of this disease burden. With our extensive respiratory portfolio and the approval of Vilfuro-G, we take immense pride in offering healthcare professionals and patients with innovative treatment solutions,” added Rajeev Sibal, President – India Region Formulations, Lupin.