terça-feira, junho 14, 2005
Tibotec procura aprovação para TMC114 e anuncia programa de acesso alargado
O programa de acesso alargado do TMC-114 começará no Outono e terá 24.000 (!) lugares para 50 países.
TMC114 Expanded Access Program for People Living with HIV/AIDS to Begin Enrollment in Autumn of 2005
Tibotec to file for accelerated approval for TMC114
YARDLEY, Pa., U.S.A., June 14, 2005 – Tibotec, Inc. announced today it plans to initiate an expanded access program (EAP) for its investigational protease inhibitor, TMC114, in the autumn of this year for people with HIV/AIDS who need the compound to construct a viable treatment regimen. The company also announced that it plans to seek accelerated approval for TMC114 in the United States and Europe through regulatory submissions filed by early 2006 based principally on the 24-week primary analyses of the company’s two phase IIB trials.
Initiation of enrollment into the expanded access program -- which will be for heavily treatment-experienced adults living with HIV/AIDS -- is contingent on the approval of local health authorities and recruitment of pivotal phase III trials. Expanded access programs provide people with severe or life-threatening illnesses with access to treatments currently being evaluated in clinical trials.
“We know that many people living with HIV/AIDS have run out of treatment options because of the increasingly significant issue of viral resistance, and we are working to provide them with access to TMC114 as soon as possible through this program,” said Paul Stoffels, M.D., President of Tibotec.
TMC114 belongs to a class of antiretroviral agents known as protease inhibitors. Protease inhibitors are commonly used in combination with other classes of anti-HIV drugs to prevent the replication of HIV in the body.
The TMC114 expanded access program will be administered by local operating entities within Johnson & Johnson, and will be supported by i3 Research in the U.S. and Parexel outside the U.S. Pending local regulatory approvals, the product will be commercialized by Tibotec Therapeutics in the U.S. and Janssen-Cilag and other affiliates outside the U.S.