Recently, a new drug to cure most cystic fibrosis patients was sanctioned by the U.S. FDA (Food and Drug Administration). Trikafta (ivacaftor/elexacaftor/tezacaftor)—from Vertex Pharmaceuticals, Inc.—is the first triple combination treatment obtainable to cure patients having the most ordinary mutation of cystic fibrosis. Apparently, its list price is about $311,000 per year, same as one of the manufacturer’s previous treatments for the genetic disease. Trikafta is sanctioned for patients aged between 12 and older, who have minimum one F508del mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene. This comprises almost 90% of cystic fibrosis patients, or approximately 27,000 people across the U.S., as per the FDA.
There are at least 2,000 identified mutations of the CFTR gene and F508del mutation is the most widespread one. Cystic fibrosis is the outcome of a flawed protein triggered by the gene mutation. The existing drugs that aim the flawed protein can be utilized to cure some patients, but a number of patients have mutations that do not react to those therapies, the FDA stated. Trikafta helps the flawed protein caused by the CFTR mutation to function more efficiently. Trikafta’s sanction is based on the outcomes of two clinical tests involving 510 patients.
On a similar note, recently, the FDA approved Swedish Match to publicize snus smokeless tobacco as less damaging than cigarettes. For the first time ever the drug administration will facilitate a tobacco firm to promote products that are less injurious than smoking cigarettes. Of late, the agency allowed Swedish Match to about 8 of its “General” snus smokeless tobacco products that have a lower peril of heart disease, mouth cancer, stroke, lung cancer, chronic bronchitis, and emphysema, than smoking. This is the very first time the FDA has sanctioned this kind of request, which is called a modified-hazard tobacco product application.
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