GlaxoSmithKline Inc., a research-based pharmaceutical company, discovers and develops medicines, vaccines, and healthcare products to customers in Canada and internationally. It offers medications for therapeutic areas and diseases, including allergies, chronic obstructive pulmonary disease, epilepsy, Parkinson's disease, asthma, depression, gastrointestinal disorders, infections, cancer, diabetes, herpes, migraine, respiratory illness, antiviral, central nervous system disorders, urology, cardiovascular, HIV/AIDS, dermatology, and oncology. The company was founded in 1902 and is based in Mississauga, Canada with regional offices in Halifax, Montreal, Toronto, and Vancouver, Canada; manufact...
7333 Mississauga Road
Mississauga, ON L5N 6L4
Founded in 1902
GlaxoSmithKline and Genmab Announces Submission to US Regulatory Authorities for Arzerra (Ofatumumab) as First Line Treatment of Chronic Lymphocytic Leukemia
Oct 19 13
GlaxoSmithKline and Genmab A/S announced the submission of a supplemental Biologics License Application to the US Food and Drug Administration (FDA) 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 application is based on results from an international, multi-center, randomized Phase III study of Arzerra in combination with chlorambucil versus chlorambucil alone in more than 400 patients with previously untreated CLL. Headline results from this trial were announced in May 2013 and the full study results are scheduled to be presented in two oral presentations at the 2013 American Society of Hematology annual meeting in December.