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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Rocketman who wrote (4918)	5/15/1998 4:54:00 PM
From: Rocketman	Respond to of 9719

FDA Panel Recommends Approval of Thyrogen Friday May 15, 4:01 pm Eastern Time Company Press Release SOURCE: Genzyme General CAMBRIDGE, Mass., May 15 /PRNewswire/ -- An advisory committee to the U.S. Food and Drug Administration today recommended approval of Genzyme General's (Nasdaq: GENZ - news) Thyrogen(R) recombinant human thyroid stimulating hormone for use in the evaluation of patients being tested for thyroid cancer metastases. Recognizing that diagnostic testing with Thyrogen is not as sensitive as testing after patients have been withdrawn from their thyroid hormone supplements, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-3 to recommend approval of Thyrogen for use in conducting thyroid scanning and thyroglobulin testing in a broad group of patients who, in the judgment of treating physicians, would benefit from the avoidance of hypothyroidism. The panel also voted 11-0 to recommend approval of Thyrogen for use in patients who otherwise would be examined solely with a serum thyroglobulin test without undergoing withdrawal from hormone supplements. In addition, the panel unanimously recommended approval of Thyrogen for use with patients who, for medical reasons, cannot be withdrawn from hormone supplements, or who cannot raise their own thyroid stimulating hormone levels adequately. In the United States, physicians order approximately 135,000 thyroglobulin tests each year for patients who have had thyroid cancer. They also perform approximately 25,000 whole body scans in such patients. Similar numbers of thyroglobulin tests and whole body scans are performed in Europe. The advisory committee's recommendation will be considered by the FDA in its final review of Genzyme General's new drug application (NDA) for Thyrogen. The recommendation is not binding on the FDA, but the agency usually follows the advice of its advisory panels. ''We are very pleased that the panel acknowledged the clinical benefits of Thyrogen and proposed an indication that we believe will make the drug available to those who need it,'' said Henri A. Termeer, Genzyme Corp.'s chairman and chief executive officer. ''Thyrogen can be a very valuable tool for physicians, and it can vastly improve the quality of life of patients who have had thyroid cancer. The panel made it clear that they would like to see physicians have the freedom to apply their clinical judgment in the use of Thyrogen.'' Thyrogen was developed for use in thyroid cancer patients who have had partial or total removal of their thyroid gland, and who therefore must take thyroid hormone supplements and undergo periodic testing for metastatic cancer. Current tests require patients to stop taking their hormone supplements for two to six weeks prior to testing. This thyroid hormone withdrawal raises the level of another hormone -- thyroid stimulating hormone (TSH) -- in the patient's bloodstream so that metastases can be detected with radioiodine scanning. But hormone withdrawal also causes fatigue, weight gain, constipation, mental dullness, lethargy, depression, and other adverse reactions. Thyrogen is an external source of TSH intended to allow diagnostic testing while avoiding hormone withdrawal and its debilitating effects. The NDA for Thyrogen was accepted by the U.S. Food and Drug Administration under the agency's priority review process. The FDA reserves priority review for therapies that may substantially improve the standard of treatment for a certain disease or condition. The priority review process requires the FDA to provide an action letter, indicating approval or non-approval, to the company within six months of FDA's receipt of the NDA. The Thyrogen application was submitted on December 12, 1997. Genzyme General develops and markets therapeutic and surgical products and diagnostic products and services. A division of biotechnology company Genzyme Corp., Genzyme General has its own common stock intended to reflect its value and track its performance. Investors may listen to a playback of a conference call discussing the outcome of the Thyrogen panel meeting by calling 1-800-633-8284 in the U.S. or 303-248-1201 elsewhere, from noon on May 18 through midnight on May 22. Reference replay reservation number 4287211. Genzyme's releases are available at genzyme.com and on the company's fax-on-demand service at 1-800-436-1443 in the U.S. or 1-201-521- 1080 elsewhere. SOURCE: Genzyme General