Ironwood Pharma Stock Soars After FDA Grants Approval For Irritable Bowel Syndrome Drug In Pediatric Patients

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Linzess is the first treatment approved for the disease in pediatric patients, the FDA said.

  • The recommended dosage for pediatric patients seven years and older with IBS-C is 145 mcg orally once daily, the FDA said.
  • Linzess is already approved for the treatment of adult patients with the condition.
  • Ironwood and AbbVie co-develop and co-commercialize the drug in the U.S. 

Shares of Ironwood Pharmaceuticals (IRWD) rose 15% on Wednesday after the U.S. Food and Drug Administration approved its Linzess capsules for pediatric patients aged seven and older with irritable bowel syndrome with constipation.

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Linzess is the first treatment approved for the disease in pediatric patients, the FDA said. Irritable bowel syndrome with constipation (IBS-C) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain associated with infrequent, hard-to-pass stools. The contributing factors to the condition are typically multiple.

The recommended dosage for pediatric patients seven years and older with IBS-C is 145 micrograms (mcg) orally once daily, the FDA said.

Risk Of Dehydration

Linzess is already approved for the treatment of adult patients with the condition. The FDA noted that the safety and efficacy of Linzess were similar in clinical studies for both adults and pediatric patients.

However, the drug poses a risk of severe dehydration in patients younger than two years of age, the FDA warned.

In the second quarter, Ironwood reported U.S. net sales of $248 million for Linzess, representing a 17% year-over-year (YoY) growth, driven by strong demand. Ironwood and AbbVie co-develop and co-commercialize the drug in the U.S.

Last week, AbbVie reported that Linzess sales in the U.S. in the third quarter were $315 million, representing a growth of 39.6% YoY.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around IRWD stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.

A Stocktwits user termed the approval a “big money maker.”

IRWD stock is down by about 52% this year.

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