On Monday, Glaxo and Genmab's new leukemia treatment drug Arzerra was awarded accelerated approval by the Food and Drug Administration. Marketing of the latest drug, which is designed to help leukemia patients who have stopped responding, or do not respond at all, to other treatments, will be undertaken by GlaxoSmithKline PLC.
Arzerra gained approval under FDA's accelerated approval scheme which is especially aimed at quickly approving medicines, the need for which is urgent. Under the said approval program, companies can obtain approval for their products based on less than traditionally required clinical data. The main aim of the accelerated approval program is to ensure that patients who face unmet medical needs can be taken care of.
While the FDA did approve the drug, it was quick to comment that further studies of Arzerra are on and the drug is being currently clinically tested on more people in addition to the initial 181 subjects taken into consideration.
Like all other drugs, Arzerra has its set of side effects which include fever, cough, fatigue and pneumonia, among others. Despite these, Arzerra is being viewed as one of the most significant drugs of the current times. "Arzerra is a significant step forward in helping patients and physicians better manage the challenges of refractory CLL. Patients now have a new choice", said Kathy Rouan, Ph.D., GlaxoSmithKline Vice President and Medicines Development Leader.
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