ViiV withdraw European application for once-daily maraviroc
On 20 September 2011, ViiV Healthcare announced that it has withdrawn its Type II Variation to the European Medicines Agency (EMA) and its Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once-daily (QD) administration of maraviroc (Celsentri/Selzentry) tablets in treatment-experienced patients infected with only CCR5-tropic HIV-1.
The submission was based on a sub-analysis of the original registrational studies in treatment-experienced patients, MOTIVATE 1 & 2. The press release stated that “although ViiV Healthcare remains committed to studying the potential for once-daily dosing of maraviroc in treatment-experienced patients, we have concluded that additional data is necessary to establish the efficacy of once-daily dosing”.
Source: ViiV Healthcare press release. Regulatory Update – Celsentri/Selzentry (maraviroc). (20 September 2011).