Genentech Inc. announced late Wednesday that it has receivedFDA approval to market Nutropin, its most recent version ofrecombinant human growth hormone, for treating growthfailure due to chronic renal insufficiency prior to kidneytransplant in children.
The FDA's Endocrinologic and Metabolic Drugs AdvisoryCommittee unanimously recommended approval of the producton Oct. 25. Genentech filed for approval on July 13, making thetotal time to a final FDA green light just 157 days. Such a rapidturnaround has been matched by few other drugs. Others towin quick FDA approval were AZT (for AIDS), which wasapproved in just 107 days, and Taxol (for advanced ovariancancer), which was approved in five months.
Nutropin's approval could have been accelerated because itssafety profile was roughly the same as that already establishedfor Genentech's FDA-approved Protropin recombinant growthhormone (for growth hormone inadequacy).
Nutropin, which differs from Protropin in that it lacks the N-terminal amino acid methionine, is actually equivalent toHumatrope, Eli Lilly's and Co.'s FDA-approved recombinanthuman growth hormone. Nutropin had been granted orphandrug status for treating chronic renal insufficiency (CRI), whichaffects about 3,000 children in the U.S. annually.
Kidney transplants can help an affected child start growingnormally again, but most children don't make up the growthlost prior to transplantation. And until now, there's been notreatment for the disease.
However, the extensive clinical trials conducted by Genentech(NYSE:GNE) of South San Francisco, Calif., demonstrated thatNutropin significantly increased the rate of growth and heightgain of children with CRI prior to renal transplantation.Moreover, that height gain was maintained into adulthood.
Genentech anticipates that Nutropin will be made availablethrough pediatric nephrologists and pediatric endocrinologistsby the end of the year. "We'll be working out the final labelingand packaging issues in the next few weeks," said Jim Weiss,Genentech's manager of corporate communications.
Nutropin is the third biotechnology drug to gain the sanction ofFDA in 1993. On July 23 the agency approved Chiron Corp. andBerlex Laboratories Inc.'s Betaseron (recombinant beta-interferon) for treating relapsing/remitting multiple sclerosis.And Kogenate, the recombinant Factor VIII product developedby Miles Inc. (but which used a gene licensed from Genentech),was approved for treating hemophilia A on Feb. 25.
In addition, on April 1, FDA approved a broader indication forOrtho Biotech Inc.'s recombinant human erythropoietin, Procrit,used to treat the anemia caused by chemotherapy in patientswith non-myeloid malignancies.
Genentech's stock closed at $48.50 a share on Wednesday,down 25 cents.
-- Jennifer Van Brunt Senior Editor
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