Cost-effectiveness of
becaplermin for nonhealing neuropathic diabetic foot ulcers.
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)
Review of records during the phase III trials of
becaplermin demonstrated that diabetic foot ulcers in treatment centers where debridements were performed most frequently were statistically more likely to heal than in centers performing the least frequent debridements[16] (Table 3).
In September 2012, the Company amended its PMA to include the results of a study conducted on
becaplermin (Regranex([R])) to evaluate cancer mortality.
4) In addition to systemic therapy, local wound care with cleansing, use of antiseptic agents and certain specific agents like topical tacrolimus, hyauronic acid,
becaplermin, lyophilized type I bovine collagen matrix have been used in few case reports.
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.
Last month, 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.
The authors compared patients taking
becaplermin with those who did not.
TABLE 24 GLOBAL BIOSIMILAR
BECAPLERMIN MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
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.
In a retrospective cohort study of 25,098 patients, 10% were treated with
becaplermin (Regranex), a topical recombinant human platelet-derived growth factor (rhPDGF).
