CFDA approves new HIV drug Tivicay®
19 January 2016
Tivicay® (dolutegravir), an innovative HIV drug from ViiV Healthcare, has received approval from the China Food and Drug Administration (CFDA) for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.
ViiV Healthcare, a joint venture in which GSK is the majority shareholder, is a global specialist HIV company.
Tivicayhas already been approved in more than seventy countries and recommended by multiple authoritative academic societies from Europe and the US as a preferred first-line combined treatment regimens for treatment-naïve HIV/AIDS patients. The World Health Organisation (WHO) also in 2015 recommended Tivicay as the alternative first line regimen for naïve patients.
In 2014 alone, 104,000 new cases of HIV infection were reported in China, a 20% increase over 2013. Moreover, the percentage of patients 24 years and younger living with HIV has been on the rise year on year. Although significant progress has been made in HIV/AIDS prevention and control, the scarcity of effective drugs and prohibitive drug prices remain the ultimate obstacle to treating HIV/AIDS infections.
Hervé Gisserot, SVP & GM of Pharmaceuticals and Vaccines, GSK China/Hong Kong, said, “The approval of Tivicay in China is a significant treatment advance for HIV/AIDS patients in China. We are working tirelessly to launch Tivicayin the Chinese market. However, in our view, launching innovative products without providing access to them, is not real innovation. Therefore, GSK's strategy to be in China, with China, for China means we are absolutely committed to making Tivicay accessible to as many patients as possible”.
The CFDA's approval of Tivicay follows the announcement in July 2015 of a strategic manufacturing agreement between ViiV Healthcare and Shanghai-based Desano Pharmaceuticals to enable the production of the medicine's active pharmaceutical ingredient (API) in China.
In addition, GSK invested one million yuan to support the Red Ribbon Health Ambassador Campus Tour campaign which is co-organised by the National Health and Family Planning Commission, the Communist Youth League of China, the AIDS Prevention and Control Working Committee Office of the State Council and the Chinese Association of STD and AIDS Prevention and Control. With GSK's support, the campaign ran promotional and educational activities at 16 major universities across China with the aim of increasing understanding of AIDS prevention and control in order to minimise the spread of the disease.