skip to main |
skip to sidebar
BioMimetic Therapeutics Addresses FDA Communication on Regranex Safety Review
March 27, 2008 - BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) addressed a communication the U.S. Food and Drug Administration ("FDA") released on its website this afternoon regarding the agency's ongoing safety review of Regranex®, a Johnson & Johnson product. Regranex is composed of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) (becaplermin) in a non-sterile ointment, which has been approved since 1997 for the chronic treatment of non-healing diabetic foot ulcers. The FDA communication specifically addresses Regranex use and does not address other rhPDGF-BB containing products. BioMimetic has not received any communications from the FDA related to today's web posting regarding Regranex.
The FDA communication provided information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) daily, directly to their dermal ulcers for up to 140 consecutive days. According to the communication, "posting this information does not mean that FDA has concluded a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product."... BioMimetic Therapeutics' Press Release -
March 27, 2008 - BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) addressed a communication the U.S. Food and Drug Administration ("FDA") released on its website this afternoon regarding the agency's ongoing safety review of Regranex®, a Johnson & Johnson product. Regranex is composed of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) (becaplermin) in a non-sterile ointment, which has been approved since 1997 for the chronic treatment of non-healing diabetic foot ulcers. The FDA communication specifically addresses Regranex use and does not address other rhPDGF-BB containing products. BioMimetic has not received any communications from the FDA related to today's web posting regarding Regranex.
The FDA communication provided information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) daily, directly to their dermal ulcers for up to 140 consecutive days. According to the communication, "posting this information does not mean that FDA has concluded a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product."... BioMimetic Therapeutics' Press Release -
