Kalydeco ivacaftor regulatory update

FDA issued a notice about the potential for cataract development in children receiving cystic fibrosis (CF) drug Kalydeco ivacaftor from Vertex based on the results of an animal study. The agency said cataracts were seen in juvenile rats treated with Kalydeco from postnatal days 7-35 at one tenth the maximum recommended human dose. FDA, which added the information to Kalydeco's label, cautioned that there is uncertainty about the relevance of cataract risk to children since there are differences in eye development between humans and rats. FDA is requiring the company to assess the potential risk of cataracts with Kalydeco in a clinical study of pediatric patients <=11 years of age. ...