New Drug for Cystic Fibrosis approved by FDA
Yesterday, the FDA announced its approval of the new drug to treat those who have the F509del mutation of Cystic Fibrosis. The announcement can be found on their website, in which the post about the new drug for Cystic Fibrosis was put up for immediate release.
What is the new drug for Cystic Fibrosis?
The new drug is called Orkambi that is a combination therapy to treat CF, featuring the chemicals ivacaftor and lumcaftor. The new drug for Cystic Fibrosis is supposed to help correct the mutated genes in the afflicted whereas before efforts were concentrated on treating the symptoms of CF.
Drug cut through some tedious wait time.
In addition to being approved by the FDA, the new drug was given the drug designation of “orphan drug” for its treatment of CF, which brings many benefits to the developers of the drug. Among those benefits are financial incentives, and other promotional deals to produce the drug. The drug has cut through some longer trial testing in the priority review of six months or so instead of the usual ten month trail because the new drug for Cystic Fibrosis is supposed to be a huge game changer.
The clinical trials had positive results which helped in the drug getting its approval by the FDA. In fact, in the study those who took two of the new drug for Cystic Fibrosis every twelve hours showed having better lung function than those who were taking the placebo.
However, the new drug for Cystic Fibrosis is not without its drawbacks as well. The common side effects of the drug in the news release are shortness of breath, upper respiratory tract infection, nausea, diarrhea, and rash that can pop up. Some women who took the drug even experienced increased menstrual bleeding and a few other things.
But there is also the fact that the drug is targeted only to a specific genetic mutation and not the disease as a whole, although some help is better than no help at all in aiding those afflicted with CF.