Becaplermin
Recombinant human platelet-derived growth factor-BB in a topical gel; the first and only pharmacological agent FDA-approved to treat a chronic wound (diabetic foot ulcers).
Overview
Platelet-derived growth factor (PDGF) is normally released by platelets and macrophages at a wound site, where it is a key driver of granulation-tissue formation. Becaplermin is the BB homodimer of PDGF produced in yeast by recombinant DNA technology, delivered in a preserved sodium-carboxymethylcellulose gel.
The pivotal phase 3 trial in 382 patients showed that becaplermin gel 100 µg/g, combined with sharp debridement and good wound care, significantly increased the incidence of complete wound closure (50% vs 35% with placebo) and reduced the time to closure. It was approved by the FDA in 1997 and marketed as Regranex.
Becaplermin carries an FDA boxed warning: an increased risk of cancer mortality was observed in patients who used three or more tubes of the product. It is applied as a thin layer once daily and covered with a moist saline dressing; the amount is calculated from ulcer dimensions.
Mechanism of Action
PDGF-BB engages PDGF receptor-β tyrosine kinases, activating downstream PI3K/Akt and MAPK signalling that drives migration, proliferation and extracellular-matrix production by fibroblasts and smooth-muscle-like cells. This recapitulates the natural PDGF signal released during haemostasis, accelerating the proliferative phase of healing in chronic wounds where endogenous growth-factor signalling is deficient.
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References (1)
- [1]Wieman TJ, Smiell JM, Su Y Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study Diabetes Care (1998)
→ Becaplermin gel 100 µg/g plus good wound care significantly increased complete closure of chronic diabetic neuropathic ulcers (50% vs 35% placebo) and shortened time to closure.
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