|FDA Advisory Committee Recommends Approval of BREO ELLIPTA; Neuralstem Wins FDA Approval to Begin Phase II Stem Cell Trial|
|By Staff and Wire Reports|
|Wednesday, 17 April 2013 18:32|
GlaxoSmithKline and Theravance (NASDAQ: THRX) announced the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US FDA voted the efficacy and safety data provide substantial evidence to support approval of BREO™ ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against)*.
BREO™ ELLIPTA™, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate "FF" and the long acting bronchodilator (LABA) vilanterol "VI" (FF/VI).
The FDA Advisory Committee also voted that the safety of FF/VI 100/25 mcg once daily in COPD has been adequately demonstrated for the proposed indications (10 for, 3 against).
Patrick Vallance, GSK's President of Pharmaceuticals, R&D, said: "We are pleased with the outcome of today's meeting. COPD is a debilitating and progressive disease. Its symptoms are often severe and can have a huge impact on patients' lives. This positive recommendation is a crucial first step towards making BREO ELLIPTA available for appropriate COPD patients across the US. We look forward to a final decision from the FDA later this year."
"After a decade of development in this programme, our collaboration with GSK is one step closer to providing an important therapeutic option to COPD patients," said Rick E Winningham, Chief Executive Officer of Theravance. "We are proud to collaborate with GSK on the development and potential commercialisation of treatments for COPD and other respiratory diseases. The panel's positive recommendation of BREO ELLIPTA represents an important achievement in a transformative year for Theravance."
In July 2012, a New Drug Application (NDA) was submitted to the FDA for the use of BREO™ administered by the ELLIPTA™ inhaler for the long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, and to reduce exacerbations of COPD in patients with a history of exacerbations.
In June 2012, a regulatory application for FF/VI was submitted in the European Union under the trade name RELVAR™ for the treatment of patients with COPD and asthma. In the United States, BREO ELLIPTA is not proposed for the relief of acute bronchospasm or for the treatment of asthma. GSK and Theravance are reviewing the strategy for a future US filing for asthma.
The FDA Advisory Committee provides non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for FF/VI is 12 May 2013.
*One panel member indicated that he intended to vote no, however a vote cannot be changed once read into the official FDA record.
Neuralstem, Inc. (NYSE: CUR) announced it has received approval from the FDA to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution.
The trial is designed to treat up to 15 patients, in five different dosing cohorts. All of the patients will be ambulatory and reside within close geographic proximity to the research center where they will participate. The first 12 patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The final three patients will receive both cervical and lumbar injections.
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