Novartis has recently
presented data which show that Ultibro, its drug for chronic obstructive pulmonary
disease (COPD), is superior in reducing flare-ups as compared to
GlaxoSmithKline's blockbuster Seretide.
The data is from the Phase III head-to-head LANTERN study that was presented at the European Respiratory Society Congress in Munich. LANTERN was a double-blind, randomised, parallel-group, 26-week study that was conducted at 56 sites in China, Argentina, Chile and Taiwan. 741 patients were assessed during the study and the safety and efficacy of Ultibro Breezhaler was compared to Seretide. All patients suffered from moderate-to-severe COPD, with or without a history of moderate-to-severe exacerbations in the previous year. The primary objective of the study was to demonstrate the non-inferiority of Ultibro Breezhaler.
The findings demonstrate that once-daily Ultibro Breezhaler (indacterol/glycopyrronium) 110/50 mcg was superior in reducing exacerbations and improving lung function as compared to twice-daily Seretide Accuhaler (salmeterol/fluticasone) 50/500 mcg. In patients with moderate-to-severe COPD, Ultibro successfully reduced the rate of moderate-to-severe exacerbations by 31 percent as compared to Seretide. Moreover, patients on Ultibro had significantly increased drug function as compared to Seretide after 26 weeks of treatment. The safety profile for both drugs remained similar.
This is the second study that confirms the performance of the Breezhaler. Previously, the ILLUMINATE study demonstrated that the Ultibro Breezhaler achieved superior lung function in patients with moderate-to-severe COPD as compared to twice daily salmeterol/fluticasone.
According to Tim Wright, Global Head of Development, Novartis Pharmaceuticals, "Such promising data will be part of a regulatory submission in China later this year and is exciting news for the COPD community and ultimately patients."
According to Vasant Narasimha, the head of development at Novartis Pharmaceuticals, the results provide further evidence of the potential of Ultibro Breezhaler to deliver better exacerbation reduction and improvements in lung function, compared to the current standard of care, namely Seretide.
Seretide contains fluticasone which is a steroid. According to Ken Chapman of the University of Toronto, there has been "substantial inappropriate use" of inhaled steroids as they are dispensed quite liberally in severe COPD cases. There are significant risks associated with such usage, including an increased risk of pneumonia, fractures and cataracts.
Novartis has also recently signed a deal with Pfizer to promote Ultibro and another COPD drug, glycopyrronium (brand name Seebri), in the UK. This drug is also delivered through the Breezhaler device. Seebri is already available in the UK while Ultibro has yet to be launched in Europe.
Source: Pharma Times.
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