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Injectable Cabotegravir/Rilpivirine, Oral - FDA, EMA
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ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly, injectable treatment for HIV
announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the investigational
This application to the EMA follows the recent submission of a New Drug Application (NDA) for the 2DR of cabotegravir and rilpivirine, as well as cabotegravir oral tablets, to the US Food and Drug Administration (FDA) in April 2019. In June, this submission was granted a Priority Review Designation by the FDA with an expected action date of December 29, 2019. ViiV Healthcare and Janssen also plan to submit additional regulatory applications for cabotegravir and rilpivirine to other regulatory agencies in the coming months.
ViiV Healthcare reports positive phase III study results of investigational, long-acting, injectable HIV-treatment regimen administered every two months
global phase III ATLAS-2M study of the investigational, long-acting, injectable, 2-drug regimen (2DR)
IDWeek: Adherence to Long-Acting Injectable Cabotegravir + Rilpivirine through 48 Weeks of Maintenance Therapy in the Phase 3 ATLAS and FLAIR Studies - (10/8/19)
IAS 2019: Long-Acting Cabotegravir and Rilpivirine is Noninferior to Oral ART as Maintenance Therapy for HIV-1 Infection: Week 48 Pooled Analysis From the Phase 3 ATLAS and FLAIR Studies
IDWeek: Long-Term Efficacy, Safety and Durability of CAB and RPV as Two-Drug Oral Maintenance Therapy - LATTE Week 312 Results - (10/15/19)
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