FDA Advisory Committee Determines REGRANEX Gel 0.01% Safe and Effective for Treatment of Diabetic Ulcers.BETHESDA, Md.--(BW HealthWire)--July 14, 1997--The Dermatologic and Ophthalmic Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) today voted that REGRANEX(R) (becaplermin) Gel 0.01% is safe and effective for the treatment of diabetic ulcers that occur on the lower limbs and feet. A Biologic Licensing Application (BLA BLA abbr. Bachelor of Liberal Arts ) for REGRANEX Gel was filed in December 1996. The product was developed jointly by the R.W. Johnson Pharmaceutical Research Institute (RWJPRI) and Chiron Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CHIR CHIR Chiricahua National Monument (US National Park Service) ). The active ingredient in REGRANEX Gel is becaplermin, the genetically engineered form of platelet-derived growth factor platelet-derived growth factor n. A substance in platelets that is mitogenic for cells at the site of a wound, causing endothelial proliferation. , a naturally occurring protein in the body that stimulates wound healing. The data from the pivotal study presented during the Advisory Committee meeting showed that REGRANEX Gel 0.01%, applied once daily in combination with good wound care, significantly increased the incidence of complete healing by 43 percent when compared to placebo gel. REGRANEX Gel also significantly decreased the time to complete healing by 32 percent (six weeks). REGRANEX Gel was reported to be safe and well tolerated in clinical trials. Incidence of adverse events including infection and cellulitis Cellulitis Definition Cellulitis is a spreading bacterial infection just below the skin surface. It is most commonly caused by Streptococcus pyogenes or Staphylococcus aureus. was similar in patients treated with REGRANEX Gel, placebo gel or good wound care alone. Diabetic foot ulcers are a serious complication of diabetes affecting 1.5 million patients each year. REGRANEX Gel was developed by PRI PRI: see Institutional Revolutionary party. (Primary Rate Interface) An ISDN service that provides 23 64 Kbps B (Bearer) channels and one 64 Kbps D (Data) channel (23B+D), which is equivalent to the 24 channels of a T1 line. and, if cleared by the FDA, will be marketed in the United States by Ortho-McNeil Pharmaceutical, both Johnson & Johnson companies located in Raritan, N.J. Under a supply agreement with Ortho-McNeil, Chiron Corp. manufactures and supplies becaplermin, the active ingredient in REGRANEX Gel. Chiron Corp., headquartered in Emeryville, Calif., is a health care company that combines diagnostic, vaccine and therapeutic strategies for controlling disease. CONTACT: Chiron Corp. Jim Knighton, 510/923-3252 or Ortho-McNeil Pharmaceutical Lorie Gawreluk, 908/218-6668 |
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