FDA approves expanded use of Omnitrope

PRINCETON, N.J. The Food and Drug Administrations has approved two new uses for what remains, thus far, the only biosimilar on the U.S. market.

Sandoz, the generics arm of Swiss drug maker Novartis, said Monday that the FDA had approved Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Prader-Willi syndrome and for those who are small for gestational age.

The company also announced changes to OmniSource, a support program for patients taking the drug, replacing the Sandoz Access program with what it called a more extensive range of programs, higher-value reimbursement and expanded insurance features. Sandoz said, for example, that patients could save up to $3,000 per year in out-of-pocket costs for Omnitrope prescriptions through the “Save As You Grow” program.

The FDA originally approved Omnitrope in May 2006 under a section of the Federal Food, Drug and Cosmetic Act for children with growth failure and as a replacement therapy for adults with growth hormone deficiency. The drug was launched in the United States in January 2007. Omnitrope is a biosimilar of Pfizer’s Genotropin.

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