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Approval in sight for GSK's triple COPD therapy
Posted 21 September 2017
GSK's triple therapy for COPD Trelegy Ellipta (vilanterol/umeclidinium/fluticasone) looks to be close to an Australian registration after it was approved in the US and given a positive recommendation in the EU.
GSK says the inhaler has been filed and is "undergoing assessment" in Australia in a company statement on last week's US approval. It is likely the drug was filed last December, around the same time as its EU filing, meaning that a registration will happen by early 2018 if not in the next quarter.
Trelegy Ellipta combines three existing GSK COPD therapies in a single once-a-day inhaler, making it a 'closed triple' as opposed to an 'open triple' where patients use multiple inhalers to administer the combination of drugs.
The more convenient treatment is expected to bring in sales of around USD1.5 billion at its peak in the US as GSK awaits the patent expiry of other respiratory medicines including Advair (fluticasone and salmeterol), marketed in Australia as Seretide Accuhaler, which saw the first generic registered on the ARTG last October.
The treatment was FDA approved for patients on a fixed-dose combination of GSK's Breo Ellipta (fluticasone and vilanterol) who require additional treatment of airflow obstruction, or patients already taking the triple combo in an open therapy, likely some combination of Breo Ellipta, Incruse Ellipta (umeclidinium), Anoro Ellipta (vilanterol and umeclidium) and Arnuity Ellipta (fluticasone) - all GSK drugs.
In Australia only Incruse and Anoro are PBS listed for COPD, making a total of $11.2 million in pre-rebate R/PBS benefits in the year to August 2017.
Breo Ellipta, listed in late 2014 along with Incruse and Anoro, made almost $18.5 million in the year to August for its asthma indication. Arnuity won a PBAC positive recommendation for asthma nearly two years ago, although a PBS listing is yet to come.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 21 September 2017
GSK's triple therapy for COPD Trelegy Ellipta (vilanterol/umeclidinium/fluticasone) looks to be close to an Australian registration after it was approved in the US and given a positive recommendation in the EU.
GSK says the inhaler has been filed and is "undergoing assessment" in Australia in a company statement on last week's US approval. It is likely the drug was filed last December, around the same time as its EU filing, meaning that a registration will happen by early 2018 if not in the next quarter.
Trelegy Ellipta combines three existing GSK COPD therapies in a single once-a-day inhaler, making it a 'closed triple' as opposed to an 'open triple' where patients use multiple inhalers to administer the combination of drugs.
The more convenient treatment is expected to bring in sales of around USD1.5 billion at its peak in the US as GSK awaits the patent expiry of other respiratory medicines including Advair (fluticasone and salmeterol), marketed in Australia as Seretide Accuhaler, which saw the first generic registered on the ARTG last October.
The treatment was FDA approved for patients on a fixed-dose combination of GSK's Breo Ellipta (fluticasone and vilanterol) who require additional treatment of airflow obstruction, or patients already taking the triple combo in an open therapy, likely some combination of Breo Ellipta, Incruse Ellipta (umeclidinium), Anoro Ellipta (vilanterol and umeclidium) and Arnuity Ellipta (fluticasone) - all GSK drugs.
In Australia only Incruse and Anoro are PBS listed for COPD, making a total of $11.2 million in pre-rebate R/PBS benefits in the year to August 2017.
Breo Ellipta, listed in late 2014 along with Incruse and Anoro, made almost $18.5 million in the year to August for its asthma indication. Arnuity won a PBAC positive recommendation for asthma nearly two years ago, although a PBS listing is yet to come.
Yajun Ma
yajun.ma@lushmedia.com.au
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