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Arzerra® receives Priority Review from FDA
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PDUFA date of April 19, 2014
COPENHAGEN, Denmark I December 17, 2013 I GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental Biologics License Application (sBLA) for the use of Arzerra® (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 19, 2014 for the sBLA for Arzerra®.
Ofatumumab is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL. For the approved indication, please visit http://us.gsk.com/html/medicines/index.html for full US Prescribing Information and http://health.gsk.com/ for the EU Summary of Product Characteristics (SPC).
About the Prescription Drug User Fee Act (PDUFA)
PDUFA is US legislation which was initially enacted in 1992 and renewed in 1997, 2002, 2007 and 2012. The legislation authorizes the FDA to collect fees from companies that produce certain drugs. These fees, called “user fees”, play an important role in expediting the drug approval process. A PDUFA date is the date by which the FDA aims to complete its review of a drug application.
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013.1 At present, no curative chemotherapy is available.
About Arzerra (ofatumumab)
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops2. Ofatumumab has been granted Breakthrough Therapy Designation from the US FDA. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and the GlaxoSmithKline group of companies.
About GlaxoSmithKline
One of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For further information please visit www.gsk.com.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
SOURCE: Genmab
Post Views: 117
-
Arzerra® receives Priority Review from FDA
-
PDUFA date of April 19, 2014
COPENHAGEN, Denmark I December 17, 2013 I GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental Biologics License Application (sBLA) for the use of Arzerra® (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 19, 2014 for the sBLA for Arzerra®.
Ofatumumab is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL. For the approved indication, please visit http://us.gsk.com/html/medicines/index.html for full US Prescribing Information and http://health.gsk.com/ for the EU Summary of Product Characteristics (SPC).
About the Prescription Drug User Fee Act (PDUFA)
PDUFA is US legislation which was initially enacted in 1992 and renewed in 1997, 2002, 2007 and 2012. The legislation authorizes the FDA to collect fees from companies that produce certain drugs. These fees, called “user fees”, play an important role in expediting the drug approval process. A PDUFA date is the date by which the FDA aims to complete its review of a drug application.
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013.1 At present, no curative chemotherapy is available.
About Arzerra (ofatumumab)
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops2. Ofatumumab has been granted Breakthrough Therapy Designation from the US FDA. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and the GlaxoSmithKline group of companies.
About GlaxoSmithKline
One of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For further information please visit www.gsk.com.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
SOURCE: Genmab
Post Views: 117
