{"id":2426,"date":"2018-03-26T17:28:16","date_gmt":"2018-03-26T21:28:16","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=2426"},"modified":"2020-07-17T13:30:37","modified_gmt":"2020-07-17T17:30:37","slug":"fda-approves-symdeko-cystic-fibrosis","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-symdeko-cystic-fibrosis\/","title":{"rendered":"FDA approves Symdeko for treatment of cystic fibrosis"},"content":{"rendered":"

Symdeko was <\/span>approved by the FDA in February 2018<\/span><\/a> for the treatment of certain types of cystic fibrosis in patients aged 12 years and older. Cystic fibrosis (CF) is estimated to affect 75,000 people across North America, Europe, and Australia, <\/span>according to Vertex Pharmaceuticals<\/span><\/a>, the company behind the drug. The president of Vertex, Jeffrey Leiden, MD, Ph.D., says Symdeko\u2019s approval by the FDA marks <\/span>\u201can exciting day for the CF community.\u201d<\/span><\/a><\/p>\n

What is cystic fibrosis?<\/b><\/h2>\n

Cystic fibrosis is a disease caused by a mutation of genes that control proteins responsible for the secretion of certain liquids in the body, which results in the thickening of sweat, digestive fluids, and mucus. This, in turn, affects the function of the pancreas, liver, intestines, reproductive organs, bladder, and kidneys, but is most impactful on the lungs. The lungs become clogged with thick mucus that causes difficulty breathing and frequent respiratory infections.<\/span><\/p>\n

What is Symdeko, and how does it work?<\/b><\/h2>\n

Symdeko<\/span><\/a> can be prescribed in patients with a specific mutation (of the CFTR gene). A combination of two drugs\u2014tezacaftor and ivacaftor\u2014Symdeko is prescribed in tablet form. The usual dose is one tablet in the morning (which contains both medications) and one tablet at night (which contains ivacaftor only). The two doses should be taken 12 hours apart. Symdeko should be taken with a fat-containing meal or snack to help the body absorb the medication. The treatment works by allowing malfunctioning proteins in a patient\u2019s respiratory membranes to work more efficiently, which results in a thinner liquid secretion in the lungs. Lung function is improved, as air is able to flow more easily.<\/span><\/p>\n

The new drug\u2019s approval comes after the FDA examined studies published in the<\/span> New England Journal of Medicine<\/span><\/i> in November 2017. These studies showed that patients aged 12 or older experienced statistically significant and clinically meaningful improvements in lung function after using Symdeko for 48 weeks.<\/span><\/p>\n

Side effects of Symdeko<\/b><\/h2>\n

The most common Symdeko <\/span>side effects<\/span><\/a> include:\u00a0<\/span><\/p>\n