Please login to the form below

Not currently logged in
Email:
Password:

TEVA's tardive dyskinesia drug wins FDA breakthrough status

SD-809 to be given development incentives
TEVA

TEVA's tardive dyskinesia drug, SD-809 has been granted breakthrough therapy designation by the FDA.

The designation comes on the back of data from the phase II/III Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD) study which enrolled 117 patients with moderate to severe degrees of the condition.

Michael Hayden, president of global R&D and chief scientific officer at TEVA, said: “The granting of breakthrough therapy designation by the FDA represents significant progress toward advancing the clinical program for SD-809, as a potential, much-needed treatment option for the underserved tardive dyskinesia patient population.

“We remain excited about studying this innovative compound across a number of indications.”

Tardive dyskinesia is a condition characterised repetitive and uncontrollable movements of the tongue, lips, face and extremities and has been associated with the use of anti-psychotic drugs.

The condition affects around 500,000 people in the United States.

Breakthrough Therapy Designation is granted to a drug that is intended to treat a serious condition and preliminary clinical evidence suggests that SD-809 (deutetrabenazine) may demonstrate substantial improvement over available therapy. 

Article by
Nikhil Patel

10th November 2015

From: Research

Share

Tags

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Dovetail

We’re a specialist health consultancy that supports companies, healthcare professionals and patients to work hand in hand with a common...

Latest intelligence

InSite Events™ National Pharma Meeting: A Customer Story
How our client leveraged Impetus Digital’s white-glove service, 360° coverage and care, and award-winning InSite Events™ platform to successfully transfer their annual national meeting online....
Fear or encouragement, which is best to drive behaviour change?
The communications industry depends on fear of the perceived loss of something, in order to create the hope found in a product benefit. But, if if left too long unchecked,...
The unheard, unseen, and uncorrected effects of COVID-19
The disproportionate effects of the pandemic have been highlighted amongst ethnic minorities, so is it likely that ethnic minorities will be more worried about participating? And could this exacerbate inequalities...

Infographics