FDA Panel OKs Drug to Treat Kidney Failure

A genetically engineered drug to help children with kidney failure keep growing won unanimous endorsement from a Food and Drug Administration advisory panel on Monday.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted, 8 to 0, to recommend approval of Genentech Inc.’s new recombinant human growth hormone, Nutropin, for children with chronic renal insufficiency.

But the panel said more studies were needed on the safety and long-term effectiveness of the treatment.

Genentech, based in South San Francisco, said 3,000 American children suffer from irreversible kidney damage that can stunt their growth. Kidney transplants can help a child start growing normally again, but most children do not make up for the growth they lost.

In a clinical trial, two-thirds of the children treated with Nutropin for two years achieved normal height.

Genentech creates the hormone using recombinant DNA technology.

The FDA normally follows the recommendations of its advisory committees in deciding whether to allow a new drug onto the market.