Like many people with a sensitivity to gluten, Kristen Sweet avoids the protein in wheat that can make her sick. But when she eats at a friend’s house or a restaurant, she cannot be certain that the food is absolutely gluten-free. “There’s this risk every time you do go out and trust your health in someone else’s hands,” said Ms. Sweet, 29, who has the gluten-related condition known as celiac disease. “When I do get sick I am curled up in a ball for days and there is nothing I can do. There is nothing you can take.”
Now, however, pharmaceutical companies are racing to develop the first drugs for celiac disease, which researchers say is much more common than previously thought. No drugs are expected to reach the market until 2018 at the earliest, but a couple of them have shown hints of promise in small clinical trials and might soon advance to the final stage of testing. With that in mind, the Food and Drug Administration held a daylong public workshop recently to discuss something it has not had to ponder before: How to measure the effectiveness of celiac disease drugs in clinical trials.
Most of the drugs in development would not eliminate the need for a gluten-free diet, but would help alleviate symptoms when some gluten does leak into food. They are being developed mainly by small companies, though some larger pharmaceutical companies are now also showing interest. AbbVie paid $70 million for an option to acquire the global rights to a drug being developed by Alvine Pharmaceuticals. GlaxoSmithKline and Avalon Ventures, a venture capital firm, created a new company, Sitari Pharmaceuticals, which is pursuing celiac treatments. read more …
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