Please login to the form below

Not currently logged in
Email:
Password:

FDA proffers guidance for new Alzheimer's drugs

Encourages approach that tackles disease in its early stages

FDA headquarters

The US FDA has developed new guidance on the development of medicines for Alzheimer's as attention shifts towards intervening earlier in the course of the disease.

Disappointing late-stage trial results for a number of drugs targeting patients in whom Alzheimer's is already taking hold - including Pfizer's bapineuzumab and Lilly's solanezumab just last year - have focused thinking on starting treatment before symptoms develop.

"The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer's disease before there is too much irreversible injury to the brain," commented Russell Katz, who heads the FDA's division of neurology products.

"It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients," he added.

Pfizer and Lilly were both tested in patients with mild-to-moderate Alzheimer's with a view to delaying cognitive and memory decline.

Pfizer decided to give up in its candidate - at least in intravenous formulation - when trials showed no benefit, although Lilly was sufficiently encouraged by an efficacy signal in a subpopulation of patients with mild disease to start a new trial in early-stage patients.

Meanwhile, Roche subsidiary Genentech has gone one step further with its crenezumab candidate, licensed from AC Immune, and will test the therapy in a healthy group of patients who are genetically at extremely high risk of developing Alzheimer's.

The new guidance explains the FDA's current thinking about the way researchers can identify and select patients with early Alzheimer's disease, as well as those who are at risk of developing the disease, for participation in clinical trials, according to the agency.

It also provides advice and information on the selection of biomarkers, trial design and more sensitive measures of mental decline.

One challenge facing developers of Alzheimer's drugs has been that, according to FDA criteria, new medicines have to show an impact on not only cognitive function, but also on overall patient functioning.

The agency notes that the principles behind this 'co-primary endpoint' approach still apply, but it recognises this may be impractical in patients who have yet to develop any overt dementia symptoms.

"Clear evidence of an effect on delaying cognitive impairment may provide sufficient evidence of effectiveness" in early-stage studies, according to the guidance.

The document is open for public comment for 60 days.

8th February 2013

From: Research, Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Ashley Communications

Ashley Communications is a bespoke, independent medical communications consultancy consistently providing a unique director-delivered client service tailored to individual client...

Latest intelligence

Is the pharma business model ready for precision medicine?
Precision medicine promises to revolutionise patient outcomes and reduce costs for industry but is pharma ready for it? Blue Latitude Health co-founder Head of Strategy Fred Bassett explores the challenges...
ABPI2018
The NHS and ABPI at 70: inching closer to the triple win
The NHS and UK pharma’s ABPI both turn 70 this year. After years of transactional relationships, there’s a will to work more closely - but friction on prices and value...
What pharma marketers can learn from behavioural science
Pharma behavioural science and traditional emotional marketing create a powerful mix of techniques that have impact on real lives....

Infographics