FDA approves Parkinson's disease drug
First NCE approved for PD patients with motor fluctuations in the US in more than a decade .
Newron Pharmaceuticals and its partners Zambon and US WorldMeds have announced that the FDA has approved the use of Xadago (safinamide) for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa.
C. Warren Olanow, MD stated: “The approval of Xadago as a treatment for patients with Parkinson’s disease by the FDA represents an important milestone as it is the first NCE approved for the treatment of Parkinson’s disease in the US in over a decade.” Dr Olanow, Professor and Chairman Emeritus of the Department of Neurology and Professor Emeritus of the Department of Neuroscience at the Mount Sinai School of Medicine in New York City continued: “Xadago as an add-on to levodopa/carbidopa provided a significant reduction in OFF time and a significant increase in ON time without troublesome dyskinesia in PD patients experiencing motor fluctuations.”
Ravi Anand, Newron’s CMO, commented: “International, randomized, clinical trials have demonstrated that Xadago significantly improves ON time, OFF time, and Parkinsonism compared to standard of care without increasing time spent with troublesome dyskinesia in patients experiencing motor fluctuations while on optimized levodopa/carbidopa therapy. In addition, the onset of improvement of motor fluctuations occurred early in treatment.”
P. Breckinridge Jones, CEO of US WorldMeds said: “We are thrilled by the FDA’s approval of Xadago and are excited to have a key role in the introduction of a new medicine for Parkinson’s disease. We will now accelerate our US launch preparations to get Xadago to Parkinson’s patients in need of new treatment options.”
Dr Charlotte Keywood, Global Head R&D, Zambon, said: "We are delighted with the approval of Xadago in the US. This first new treatment for a decade represents an important addition to the treatment choices for patients with PD and their doctors. To more fully characterize the clinical benefits of Xadago, Zambon will continue to work with our partners on new clinical trials."
Marketing authorization in the EU for Xadago was granted by the EU Commission in February 2015, and by Swissmedic in November 2015. Following the 2015 European approval and the launch in Germany, Xadago has been launched by Zambon in 10 further European markets in 2016 including Italy, Spain, UK, Belgium, Denmark, Sweden, Luxembourg, the Netherlands, Norway, and Switzerland.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance