New formulation of Oncaspar receives Marketing Authorization in Europe for patients with ALL
Freeze-dried, or lyophilized, formulation aims to improve supply management by providing the same dosing regimen as liquid Oncaspar but with a three-times longer shelf life of up to 24 months.
The European Commission (EC) has granted Marketing Authorization for Shire's lyophilized Oncaspar (pegaspargase), as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL) in pediatric patients from birth to 18 years, and in adult patients. The approval – which authorizes Shire to market lyophilized Oncaspar in the 28 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway – follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 12 October.
“This approval underscores Shire’s commitment to patients with acute lymphoblastic leukemia through continued research and evolution of asparaginase therapy,” said Howard B. Mayer, SVP and ad-interim Head, Global Research and Development, Shire. “With this lyophilized formulation, we aim to make pegylated asparaginase, part of the pediatric standard therapy in acute lymphoblastic leukemia, available to patients in countries where liquid Oncaspar is not currently offered. Additionally, with extended shelf life up to 24 months, treatment centers will have flexibility in inventory management to help ensure continuous treatment supply for patients.”
Lyophilized Oncaspar builds on more than a decade of data and research with liquid Oncaspar, a pegylated asparaginase, and works the same way as the liquid formulation. By depleting serum L-asparagine levels and thereby interfering with protein synthesis, Oncaspar deprives lymphoblasts of L-asparagine, resulting in cell death.
The new lyophilized formulation offers the same dosing regimen as liquid Oncaspar, but with a three-times longer shelf life than the liquid formulation. Asparaginase is a critical component of the treatment regimen for ALL patients as it is a proven approach to inducing leukemic cell death.
Shire expects lyophilized Oncaspar to be available in European markets beginning in the first half of 2018.
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