The complete response letter communicated the need for Lilly interview an additional clinical study before re – submitting. – Says Lilly on further discussions with the FDA to the items outlined in the letter to address and enter the requested information as soon as possible, said Eiry Roberts, Vice President, autoimmune, bone – muscle-joint, Liprotamase Product Development at Lilly. We look forward to working with the Agency and the cystic fibrosis community, enable this important treatment option for patients. .
People with EPI have made very low or none of the digestive enzymes of the pancreas – lipase, Amylase and protease – in their small intestine, which improper digestion and absorption of fat, carbohydrates and proteins, which are often treatment with experts. EPI occurs very frequently in patients with cystic fibrosis and other diseases including chronic pancreatitis and pancreatectomy. (more…)