NPS Pharma says FDA extends review of its drug Natpara by 3 months; decision due Jan. 24

IndustriesAssociated Press

NPS Pharmaceuticals says the Food and Drug Administration won't make a decision on its drug Natpara on Friday and will extend its review by three months.

The company said Thursday that the FDA is now scheduled to make a decision on Natpara by Jan. 24. NPS said the FDA wants more time to review additional material, and it said the agency also wants NPS to submit a plan to help understand and mitigate the risks of the drug. The company said the agency hasn't asked it to run more clinical trials of Natpara but said it expects to be required to run a study after the drug is approved.

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Natpara is designed to treat a rare condition called hypoparathyroidism, in which the body produces insufficient levels of parathyroid hormone. That hormone plays a key role in controlling the body's serum calcium and phosphate levels as well as activating vitamin D.

Shares of NPS Pharmaceuticals Inc. shed $1.08, or 3.7 percent, to $28 in aftermarket trading. The stock rose 5.1 percent during regular trading.

The Bedminster, New Jersey, company also developed the drug Gattex, a treatment for a condition called short bowel syndrome. The disease is a chronic ailment that prevents patients from absorbing nutrients from food.