FDA Approves Expanded Use of Orkambi in Young Cystic Fibrosis Patients

Orkambi pic
Orkambi
Image: investors.vrtx.com

A physician and surgeon focused on ear, nose, and throat issues, Dr. William B. Clark treats patients through ENT Associates of Northwest Florida, a practice he owns. Outside of his professional life, Dr. William B. Clark has provided support to various nonprofit organizations, including those working to fight cystic fibrosis.

An additional 2,400 children who have cystic fibrosis now have a new treatment option available to them. The US Food and Drug Administration (FDA) recently gave its approval for the expanded use of Orkambi, also known as lumacaftor/ivacaftor, for children age 6 to 11 who have two copies of gene mutation F508del. Factoring in this new cohort, nearly 11,000 children in the country are now eligible to be treated with the drug.

Vertex Pharmaceuticals is behind the drug’s development, which was aided by considerable funding and support from the Cystic Fibrosis Foundation. The company is currently in the third phase of a clinical trial that it hopes will allow for the use of the drug by patients from 2 to 5 years old.

Ear Tubes to Treat Chronic Childhood Ear Infections

Chronic Childhood Ear Infections pic
Chronic Childhood Ear Infections
Image: webmd.com

An expert in treating nose, ear, and throat conditions, otolaryngologist Dr. William B. Clark practices in northwest Florida. As well as evaluating patients’ symptoms, Dr. William B. Clark performs surgeries such as the insertion of ear tubes to relieve pressure.

The majority of kids have experienced a viral or bacterial ear infection before they turn five. In many cases, these common conditions resolve themselves on their own. However, sometimes they become a chronic problem and cause ongoing ear pain and difficulty hearing. As a result, these children might experience trouble sleeping, difficulties in school, or behavioral issues. Trouble with speech or balance may also occur.

If a child is experiencing these symptoms, a doctor might recommend that the child get ear tubes, which can decrease the likelihood of future infections as well as the risk of hearing loss. The procedure, which over a half million children receive each year, typically takes about fifteen minutes while the patient is under general anesthesia. Afterward, the patient usually experiences little discomfort, and hearing issues caused by fluid in the middle ear go away right away. However, other problems, such as problems related to speaking and maintaining balance, may take a few weeks or months to resolve. A doctor can provide more information on the ear tube insertion procedure, as well as its potential benefits and risks.