FDA intends to loosen the rules for approving new Alzheimer’s disease treatments, the agency said in a proposal that ran in the New England Journal of Medicine. The pathway to approval currently lies in studies which demonstrate both that patients have improved in their ability to think and remember as well as in daily activities like eating, washing and dressing themselves. The draft guidelines would expand drug approval criteria for those at early stages of the disease. Those with no apparent symptoms may now be studied with cognitive tests and those with mild symptoms can be studied via a combined test of function and cognition.
In other FDA news, the agency’s Greg Geba announced he’s stepping down as director of the Office of Generic Drugs ahead of a “realignment of the OGD’s CMC functions and movement of the chemistry divisions into the proposed new Office of Pharmaceutical Quality” that “inevitably resets the scope of responsibilities and remit of our office.” He said the change, along with family needs, prompted the move and hailed the office’s staff for issuing nearly 600 complete response letters and 200 ANDA approvals since the Generic Drug User Fee Act was implemented in October, thereby reducing the backlog of pending applications from 2,762 in September to 2,166.
