AstraZeneca to Target Nexium at Babies Under 1 Year Old

AstraZeneca has submitted a new drug application asking for approval to market Nexium for babies less than one year old. The company believes the drug is an appropriate short-term, second-line treatment for gastroesophageal reflux disease (GERD). The application raises some interesting questions. It is well-known that babies throw up and spit up a lot, but it is much less well-known whether those are symptoms (along with crying, etc.) of GERD.

(It's also worth bearing in mind that GERD itself is a condition that was only "discovered" in the late 1980s. See this study of the condition, which says "only few data exist on the epidemiology of reflux disease," and doesn't even use the name GERD name. The rise of GERD correlates exactly with the rise of more sophisticated and lucrative antacid drugs.)

AZ's application is also an interesting in terms of the drug industry's habit of wanting to get its meds into younger and younger and patients. That trend has had an unhappy history in Canada and the U.S., where sales of heartburn drugs to kids resulted lawsuits.

More recently, the FDA has organized a voluntary ban on sales of cold medicines to children, and the agency has begun resisting the use of antipsychotics in the under-aged. (The latter development resulted in a suit on Texas.)

Also note that the sNDA is for "short-term" and "second-line" use (after lifestyle changes). History tell us that short-term often becomes long-term, and second-line often becomes first-line. Besides, how is a baby going to change its "lifestyle" if its parents are already frustrated enough to visit the doctor?

AZ notes there are currently few medications available for infant GERD. Perhaps this is explained by the Mayo Clinic's info page on the topic:

It's probably tougher on you than on your baby. Even when soaked in spit up, most babies who have infant acid reflux are healthy and content.

... Infant acid reflux typically resolves on its own by ages 12 to 18 months. In the meantime, changes in feeding technique -- such as smaller, more frequent feedings, changing position or interrupting feedings to burp -- can help keep reflux under control. In a few cases, medication or other treatments may be recommended.