13 February 2018
The DDF welcomes new draft guidance from the FDA that endorses a new approach in Alzheimer’s Disease research that would rely on an improvement in biomarkers to approve medicines before patients show any signs of the illness, instead of demonstrating that a drug alleviates symptoms. To entice researchers, the FDA has said it would accelerate approval of a drug for people who do not yet indicate they have the disease, if the treatment has an effect on a biomarker. DDF, which was launched in 2015 to identify and evaluate novel approaches for the treatment of dementia, welcomes the new protocol which, according to the new draft guidance released by FDA in February 2018, will help to ease drug development for Alzheimer’s disease.
Tetsu Maruyama Ph.D., Chief Scientific Officer of the DDF, said: “DDF’s dedicated team of neuroscientists and experts are working closely together with industry and its strategic investors, including the UK’s Department of Health and charity Alzheimer’s Research UK, to identify and evaluate novel approaches for the treatment of dementia, including Alzheimer’s disease. To date there are no safe, efficacious and meaningful medicines to treat this major disease area. DDF is investing in truly novel, early-stage projects starting from target identification, and exploring novel biological insights for translation of science into disease-modifying drugs and we welcome this move by FDA.”
See Bill Gates’ recent blog post here