Questions Snag Muscular Dystrophy Drug’s FDA Progress
In addition, the Food and Drug Administration has delayed a decision about whether to add folic acid to corn masa.
The Wall Street Journal:
Muscular Dystrophy Drugs Face New FDA Questions
Hopes are dimming that the drug industry will be able to quickly deliver a treatment for one of the most keenly researched diseases of recent years—an inherited muscle-wasting disorder called Duchenne muscular dystrophy. Amid intense pressure from patients’ families, the U.S. Food and Drug Administration agreed to expedite its review of a pair of experimental drugs from BioMarin Pharmaceutical Inc. and Sarepta Therapeutics. But last week the FDA rejected BioMarin’s application to sell its drug, drisapersen. ... And on Friday, FDA scientists said the benefits of Sarepta’s drug appeared inconsistent in a small clinical trial, and questioned the methodology of the research. (Whaler and Dockser Marcus, 1/20)
The Seattle Times:
FDA Delays Decision On Adding Folic Acid To Corn Masa
Federal regulators have delayed until April a decision on whether to allow folic acid to be added to corn-masa flour, a move experts say could help prevent birth defects like those seen in a deadly cluster in three Central Washington counties. The Food and Drug Administration (FDA) has notified officials with the March of Dimes that the agency will take 90 additional days beyond a mid-January deadline to continue review of a petition urging voluntary fortification of corn masa, a grain common in Latino diets. Enriched wheat and rice flours have been required to be fortified for nearly 20 years. (Aleccia, 1/20)