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Vertex Pharmaceutical’s new next-in-class, triple combination modulator has been submitted for approval to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with the Australian approval process for those aged 6+ planned to start later this year!

This follows the recently announced results of late-stage clinical trials showing that the new once-daily treatment (instead of the twice-daily Trikafta), produced similar improvements in lung function compared to Trikafta, with greater improvements in sweat chloride seen in children.

The 52-week trial in people with CF aged 12 years and older, who have at least one F508del mutation or a mutation responsive to triple combination CFTR modulators, found that the new triple combination met all primary and secondary endpoints. Similarly, a 24-week trial tested the new therapy in children aged 6-11 years and was also found to be safe and well tolerated in this cohort.

CFCC welcomes this news and looks forward to this new, once daily medication being submitted in Australia, improving both convenience and providing a vital alternative treatment option for those with CF in Australia.

Read more about the new triple combination here. 


 

13 May 2024
Category: News
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