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FDA gives orphan status to drug to treat carcinoid syndrome

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Lexicon Pharmaceuticals continues to receive incentives from the Food & Drug Administration to keep developing the drug telotristat for the treatment of carcinoid syndrome, a condition caused by tumors in the GI tract.

The FDA has awarded orphan drug status to telotristat. The company's drug was previously awarded fast-track status as well, allowing Lexicon to submit its marketing application in stages and not all at once, giving them more interaction with FDA regulators and even, potentially, a priority review.

Telotristat is an oral drug that reduces serotonin levels. Tumors from carcinoid syndrome cause an increased production of serotonin, amounting to a variety of side effects including severe diarrhea.

Source: Therapeutics Daily

 

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