Genmab achieves breakthrough as FDA approves Arzerra  

2009.10.30
Genmab and GlaxoSmithKline have received accelerated approval of Arzerra (ofatumumab) from the US Food and Drug Administration
Danish biotech company Genmab and US pharma giant GlaxoSmithKline (GSK) have received accelerated approval of Arzerra (ofatumumab) from the US Food and Drug Administration for use in patients with chronic lymphocytic leukemia (CCL) that is refractory to fludarabine and alemtuzumab (two therapies used for treating CCL). The news is reported in a press release from Genmab and by national daily newspaper Berlingske Tidende.
 
The FDA's approval of Arzerra for the above mentioned indications has triggered a milestone payment to Genmab of approx. DKK 116m (approx. USD 23m).  Arzerra is expected to become available on prescription in the US in a few weeks time.
 
The company's CEO, Lisa N. Drakeman, writes in a company press release: "The approval of Arzerra marks a key milestone for Genmab as it is our first antibody to reach the market. We are happy that we can now offer a new treatment to these refractory CLL patients, especially as it is Genmab's goal to develop products for life threatening and debilitating unmet medical needs."
 
Genmab creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. The company's pipeline of fully human antibodies consists of 7 products in clinical development as well as several pre-clinical programmes and disease targets under exploration. Genmab is listed on the OMX Nordic Exchange Copenhagen.
 
Link > Genmab                    

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