[color=blue]Biogen[/color] wrote:Tecfidera had a statistically significant effect on all of the relapse and MRI endpoints described above. There was no statistically significant effect on disability progression. The Tecfidera 240 mg three times daily dose resulted in no additional benefit over the Tecfidera 240 mg twice daily dose.
· · · · · · · · · · · · · · · · · · · Tecfidera · Placebo · P ·
Proportion with disability progression · 13% · · · · 17% · 0.25
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So, rats given effective doses lower than the prescribed dose for people developed stomach cancers yet there's no comment if any carcinogenic effects were seen in people[color=blue]Biogen[/color] wrote:Carcinogenicity studies of dimethyl fumarate (DMF) were conducted in mice and rats. In mice, oral administration of DMF (25, 75, 200, and 400 mg/kg/day) for up to two years resulted in an increase in nonglandular stomach (forestomach) and kidney tumors: squamous cell carcinomas and papillomas of the forestomach in males and females at 200 and 400 mg/kg/day; leiomyosarcomas of the forestomach at 400 mg/kg/day in males and females; renal tubular adenomas and carcinomas at 200 and 400 mg/kg/day in males; and renal tubule adenomas at 400 mg/kg/day in females. Plasma MMF exposure (AUC) at the highest dose not associated with tumors in mice (75 mg/kg/day) was similar to that in humans at the recommended human dose (RHD) of 480 mg/day.
In rats, oral administration of DMF (25, 50, 100, and 150 mg/kg/day) for up to two years resulted in increases in squamous cell carcinomas and papillomas of the forestomach at all doses tested in males and females, and in testicular interstitial (Leydig) cell adenomas at 100 and 150 mg/kg/day. Plasma MMF AUC at the lowest dose tested was lower than that in humans at the RHD.
[color=blue]Biogen[/color] wrote:Testicular toxicity (germinal epithelial degeneration, atrophy, hypospermia, and/or hyperplasia) was observed at clinically relevant doses in mice, rats, and dogs in subchronic and chronic oral toxicity studies of DMF, and in a chronic oral toxicity study evaluating a combination of four fumaric acid esters (including DMF) in rats.