Monday, May 11, 2015

Further Data on Diabetic Retinopathy Drug Requested

Diabetes is due to either the pancreas not producing enough insulin or the cells of the body not responding properly to the insulin produced. Patients with high blood sugar will typically experience polyuria (frequent urination), they will become increasingly thirsty (polydipsia) and hungry (polyphagia). Prevention and treatment involve a healthy diet, physical exercise, not using tobacco and being a normal body weight.

Eli Lilly and Company has received an approvable letter from the FDA requesting additional supporting data for its new drug application for ruboxistaurin mesylate (proposed trade name: Arxxant), Lilly's investigational oral therapy for diabetic retinopathy.

The company plans to meet with the FDA to determine whether a new study is required to meet the request or if data from an ongoing study will suffice.

“We will be working closely with the FDA to address issues outlined in the approvable letter and to define the pathway forward,” said Timothy R. Franson, MD, the company's vice president of global regulatory affairs.

Last but not least, if kidney damage has been formed by diabetes, the medical treatment should be applied as early as possible. In our Chronic Kidney Disease (CKD) Center, we do use Blood Pollution Therapy to deal with kidney damage. The treatment aims at treating the polluted blood not the kidneys. Under help of various techniques of cleaning blood, the wastes and toxins in blood can be discharged effectively and in the way, the internal environment of the body can be cleaned. Then, some effective reprative medicine and different elements can be supplied.

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