On April 18, the European Commission (EC) approved a generic formulation of somatropin ( Omnitrope, made by Sandoz, a Novartis AG company), recognizing the safety and efficacy of the product.
Somatropin is a recombinant DNA human growth hormone biologic intended for pediatric use as hormone replacement in the long-term treatment of growth failure due to inadequate secretion of endogenous growth hormone or Prader-Willi syndrome, and for the treatment of infants born small for gestational age who fail to manifest catch-up growth by age 2 years. Somatropin is also used as long-term replacement therapy in adults with growth hormone deficiency of childhood or adult onset.
The generic product was previously approved by the Australian Therapeutic Goods Administration in October 2004 and has been marketed in the country since November 2005.
In September 2004, the US Food and Drug Administration (FDA) deferred approval of the generic biologic due to uncertainty regarding legal and scientific issues. Although the FDA completed its review and did not identify any deficiencies in the application, the agency was unable to reach a final decision on whether to grant its approval. According to the news release, the company is hopeful that European acceptance of the product will lead to its approval by the FDA.
Tacrolimus (Prograf) for Preventing Heart Transplant Rejection in EU
On April 24, the European Commission approved a new indication for tacrolimus ( Prograf capsules and injection, made by Astellas Pharma), allowing its use for the prophylaxis of graft rejection in heart transplant recipients. The immunosuppressant drug was previously approved for use in recipients of liver and kidney transplants.
The approval was based on data from 2 trials (1 conducted in the US and 1 in Europe) that compared the safety and effectiveness of tacrolimus- and cyclosporine-based immunosuppressive regimens in heart transplantation.
Results of the studies showed that use of tacrolimus and cyclosporine yielded similar survival rates at 12 and 18 months, respectively (93.5% for tacrolimus vs 86.1% for cyclosporine at 12 months; 91.7% for tacrolimus vs 89.8% for cyclosporine at 18 months).
Tacrolimus is linked to risks for neurotoxicity, renal function impairment, infection, and posttransplant diabetes mellitus. As with most such regimens, use of tacrolimus-based immunosuppression is also linked to an increased risk of malignancies, particularly nonmelanoma skin cancers.
Tacrolimus was previously approved for this indication by the US Food and Drug Administration on March 30, 2006.
Cetrorelix Acetate Injection (Cetrotide) for in-Vitro Fertilization in Japan
On April 20, Japan's Ministry of Health, Labor, and Welfare approved cetrorelix acetate injection ( Cetrotide , made by Nippon Kayaku Company, Ltd, and Shionogi and Company, Ltd, under license from AEterna Zentaris, Inc) for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian stimulation.
By preventing premature ovulation, the drug is intended to improve success rates for women undergoing in-vitro fertilization.
Cetrorelix has been marketed worldwide by Serono SA since 1999. According to a company news release, the drug will be launched in Japan by the end of 2006.
Reviewed by Gary D. Vogin, MD
Medscape Medical News © 2006 Medscape
Cite this: Yael Waknine . International Approvals: Omnitrope, Prograf, Cetrotide - Medscape - May 01, 2006.