In regulatory news in April, clinical trials were being planned for an immunosuppressive drug, and a diabetes drug was approved.
* Isotechnika Inc. of Edmonton, Canada, announced that the Food and Drug Administration has given approval for the company to begin human clinical trials with the immunosuppressive drug ISAtx247. The company said on April 25 that it clinical trials are expected to start during the first week of May in the United States and shortly thereafter in Canada. In the United States, the trials will be conducted by Covance Inc. of Madison, Wisc. Phase I testing is expected to be completed by fall. ISAtx247 is designed for the prevention of organ rejection after transplantation and for the treatment of autoimmune diseases including arthritis and psoriasis.
* Aventis Pharmaceuticals of Parsippany, N.J., said on April 24 that the Food and Drug Administration has approved Lantus (insulin glargine injection) for the treatment of diabetes, and the product is expected to be available to patients later this year. Lantus is indicated for once-daily subcutaneous administration at bedtime in the treatment of adults with type 2 diabetes who require long-acting insulin for the control of hyperglycemia; it is also indicated for adults and children with type 1 diabetes. Aventis said that the drug provides "a relatively constant profile with no pronounced peak with a glucose-lowering effect over 24 hours."
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