To read about Regranex and FDA's follow-up communication go to: Becaplermin
(marketed as Regranex) Information Update of Safety Review: Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Regranex (becaplermin
In September 2012, the Company amended its PMA to include the results of a study conducted on becaplermin
(Regranex([R])) to evaluate cancer mortality.
Information about the increased risk of cancer-related deaths in patients who have used three or more tubes of becaplermin is now included in a boxed warning on the label of the diabetic foot and leg ulcer treatment.
The Food and Drug Administration announced that the warning had been added to the label of becaplermin (Regranex), a recombinant human platelet-derived growth factor that was approved in 1997.
The risk of death from cancer may be increased in patients prescribed becaplermin
(Regranex) more than three times, according to a statement issued by the Food and Drug Administration.
TABLE 24 GLOBAL BIOSIMILAR BECAPLERMIN
MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
01% contains becaplermin
, a human platelet-derived growth factor that is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.
CHICAGO -- Diabetic neuropathic foot ulcers treated with becaplermin
were 30% more likely to heal during a 20-week study period than ulcers not treated with the drug.
9%) confirmed cancers among 1,622 becaplermin
initiators and 86 (3.
Chiron Corporation supplies becaplermin
, the active ingredient in REGRANEX Gel, to Ortho-McNeil Pharmaceutical Inc.
The active ingredient in REGRANEX Gel is becaplermin
, the genetically engineered form of platelet-derived growth factor, a naturally occurring protein in the body that stimulates wound healing.
We found that, together, the two out-performed all control groups, including the only FDA-approved growth factor-containing drug for treating diabetic wounds, becaplermin
," said first author, Tatiana Demidova-Rice, Ph.