Smith & Nephew: FDA OKs removal of med warning as studies show safety

Smith & Nephew (LSE:SN, NYSE:SNN), the global medical technology business, announces that the U.S. Food and Drug Administration (FDA) has approved the removal of the boxed warning regarding increased rate of mortality secondary to malignancy from the prescribing information of REGRANEX gel.

This decision is based on an evaluation of multiple post-market studies that demonstrated no increased safety risk with the use of REGRANEX gel.^1,2 The boxed warning was added to the REGRANEX gel label in 2008 following an initial retrospective study using medical claims database. Smith & Nephew submitted data to the FDA to petition for the removal of the boxed warning, they included results from an extension of the initial retrospective study and two additional postmarketing studies.

The three-year extension of the initial retrospective study observed that the additional mortality data attenuated the earlier safety signal. A retrospective study using medical claims from the Veteran Affairs health care database of patients without prior cancer evaluated 6,429 REGRANEX gel users compared to 6,429 patients without REGRANEX gel treatment over 11 years and provided substantial evidence for no increased incident cancer or cancer mortality with REGRANEX gel use.

A second retrospective study using medical claims from the Veteran Affairs health care database of patients with prior cancer. The study evaluated patients with recently diagnosed malignancy in the prior one, two or three years before REGRANEX gel use compared to patients that did not receive REGRANEX gel over an 11-year study period. The rate of death due to cancer was similar in both groups and showed no evidence for increased risk of cancer death with the highest REGRANEX gel use.

REGRANEX gel is the first and only FDA-approved recombinant platelet-derived growth factor therapy for the treatment of lower extremity diabetic neuropathic ulcers. An estimated 15% of diabetics experience such diabetic foot ulcers in their lifetime. REGRANEX gel helps to heal these types of wounds an average of six weeks earlier than placebo gels, and is shown to provide a greater incidence of complete closure at 20 weeks compared to standard of care.²

https://www.marketscreener.com/SMITH-NEPHEW-9590181/news/Smith-Nephew-FDA-approves-removal-of-boxed-warning-from-REGRANEX-loz-becaplermin-gel-0-01-a-27709802/