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The EC has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat pts (≥6yrs.) with cystic fibrosis (CF), having ≥1 non-class I mutation in the CFTR gene; regulatory review is ongoing in Canada, Switzerland, Australia, & New Zealand
In 2 H2H trials, Alyftrek + ivacaftor matched Kaftrio (ivacaftor/tezacaftor/elexacaftor) on ppFEV1 & showed superiority in reducing sweat chloride…
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The CHMP has recommended Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Alyftrek is approved in the US and UK and is under review in Canada, Switzerland, Australia, and New Zealand
Vanzacaftor &…
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In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have covered Trikafta/Kaftrio as the top-performing drug of the month
Trikafta is a combination of ivacaftor, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis in pediatric patients who have at least one…
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The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023
In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

