GSK's triple therapy Trelegy Ellipta gains US approval in asthma

GlaxoSmithKline and Innoviva announced that the FDA approved a new indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include the treatment of asthma in patients aged 18 years and older. The company noted that the decision makes the product the first once-daily single inhaler triple therapy authorised for the maintenance treatment of both asthma and chronic obstructive pulmonary disease (COPD).

Hal Barron, GlaxoSmithKline's chief scientific officer, remarked "millions of asthma patients in the US rely on multiple inhalers to help control their condition and manage their symptoms. Today's approval is an important advance for these patients as it allows them to benefit from triple therapy by using one inhaler, once-a-day." Trelegy Ellipta is not indicated for the relief of acute bronchospasm.

Approval was supported by data from the CAPTAIN study, which showed that in patients uncontrolled on inhaled corticosteroids/long-acting beta agonist (ICS/LABA) combination therapy, the added bronchodilation provided by Trelegy led to significant improvements in lung function compared to Breo Ellipta (fluticasone furoate/vilanterol). The results were recently presented at the European Respiratory Society (ERS) congress.

According to GlaxoSmithKline, existing triple therapies account for only about 1% of the total US asthma market because of the inconvenience of using multiple inhalers with different dosing schedules. "Trelegy would simplify that with a once-daily inhalation from one device," noted Andrew Thomas, vice president of the company's US respiratory business. He added "this builds on the strong foundation we've seen with Trelegy in COPD," where sales of the product more than tripled to reach £518 million ($671 million) last year.

Trelegy Ellipta gained US approval in 2017 for the maintenance treatment of patients with COPD who are on Breo Ellipta for airflow obstruction and reducing exacerbations among those for whom additional treatment of airflow obstruction is desired or patients who are on Incruse Ellipta (umeclidinium) and Breo Ellipta. In July, AstraZeneca's single-inhaler, fixed dose triple-combination Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) won US approval for maintenance treatment of patients with COPD.

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