With few effective treatments available for children with severe heartburn, federal health regulators plan a quicker-than-normal approval process for a drug made by Lake Forest-based TAP Pharmaceutical Products Inc.
Already a popular treatment for adults, TAP’s Prevacid has been granted a priority review by the U.S. Food and Drug Administration to expand the drug’s label to include pediatric use. TAP could win approval for a pediatric indication in less than six months, compared with a typical FDA review of at least a year.
The FDA deems gastroesophageal reflux disease, commonly known as GERD, a serious problem because it causes many children to resist eating.
GERD typically causes food and gastric acid to flow up from the stomach into the esophagus, where tissue damage can occur and result in chest and stomach pains and difficulty swallowing. TAP is seeking approval to label the drug in treating children between the ages of 1 and 11.
As many as 10 million children in the U.S. alone could benefit from an FDA-approved treatment for GERD, said Caroline McGraw, co-director for the San Diego-based Pediatric/Adolescent Gastroesophageal Reflux Association. “The existing treatments are all adult medications that could be used, but there haven’t been [FDA] safety and efficacy studies,” McGraw said.
An early OK from the FDA could be just what TAP needs to re-invigorate Prevacid’s U.S. sales, which fell 4 percent in the first quarter, to $703 million, from a year ago.
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Prevacid is facing increased competition from heartburn drugs like Nexium, a new treatment launched last year by AstraZeneca PLC to replace Prilosec, the company’s popular purple pill. Prilosec generated $4.6 billion in sales last year and was the nation’s No. 2-selling drug. AstraZeneca doesn’t have approved labeling for pediatric use in either drug but plans to pursue such indications.
Prevacid was the nation’s No. 4-selling drug last year, generating nearly $3.6 billion in revenue for TAP, a 50-50 joint venture of North Chicago-based Abbott Laboratories and Takeda Chemical Industries of Japan.
Provena sells unit: Provena Health, amid a plan to execute a financial turnaround, has sold its durable medical equipment business to a California-based company for an undisclosed amount.
Pulmocare Medical Supply Inc. operates 10 medical equipment stores, and it offers a home infusion therapy service.
The buyer, Apria Healthcare Group, operates a national chain of home-care businesses.
Frankfort-based Provena, which operates seven hospitals in Illinois, “wants to focus on patient care, resident care in its nursing homes and long-term care facilities, and home health,” said Provena spokesman Clint Giese.
Drug discount card: Seniors interested in obtaining a new drug discount card being developed by Abbott Laboratories and six other drugmakers now have a way to get it. Unveiled last week, the Together Rx Card is available by calling 800-865-7211. Discounts of 20 percent or more will be available sometime in June, the drug companies said.