May 19, 2017
TLC Submits Marketing Authorization Application in Europe for TLC177
TLC (4152:TT) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for TLC177 (liposomal doxorubicin) in the treatment of breast cancer and ovarian cancer. The MAA filing is supported by data from a study demonstrating bioequivalence with a reference drug (Caelyx®) in measurements of total drug form, doxorubicinol (the major metabolite) and liposome-encapsulated doxorubicin.
“We are pleased to take the next step toward introducing TLC177 in Europe,” commented TLC President George Yeh. “Achieving this milestone reflects our expertise in the design and scalable production of non-biological complex drugs. In addition, TLC177 development represents our aim to bring needed therapies to major markets across the globe, as the small number of suppliers of difficult-to-produce liposomal products has resulted in difficulties in access for patients in the recent past. The planned launch of TLC177 will help ensure a robust supply for a type of therapy used to treat two very common cancers among women.”
Source：2013 Taiwan Liposome Company, Ltd.
http://www.tlcbio.com/en-global/MediaDownloadContent/media_download/Content/86
“We are pleased to take the next step toward introducing TLC177 in Europe,” commented TLC President George Yeh. “Achieving this milestone reflects our expertise in the design and scalable production of non-biological complex drugs. In addition, TLC177 development represents our aim to bring needed therapies to major markets across the globe, as the small number of suppliers of difficult-to-produce liposomal products has resulted in difficulties in access for patients in the recent past. The planned launch of TLC177 will help ensure a robust supply for a type of therapy used to treat two very common cancers among women.”
Source：2013 Taiwan Liposome Company, Ltd.
http://www.tlcbio.com/en-global/MediaDownloadContent/media_download/Content/86