Rilpivirine was developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Rilpivirine is a tablet dosed at 25mg taken once a day in combination with other antiviral agents. The overall safety profile of rilpivirine is based on Phase III clinical studies. In the rilpivirine arm, the most frequently reported adverse drug reactions (greater than or equal to 2%) that were at least of moderate intensity were depression (3.5%), insomnia (2.9%), headache (2.6%) and rash (2.2%).
Rilpivirine is available in the United States (US) and the European Union as part of a once daily fixed dose antiretroviral combination with Gilead Sciences Inc.'s tenofovir and emtricitabine. This combination, known as COMPLERA(R) (US) or EVIPLERA(R), was granted marketing authorisation from the Food and Drug Administration in August 2011, with Gilead Sciences Inc. being the marketing authorisation holder in the US, and from the European Commission in November 2011, with Gilead Sciences International Ltd. being the marketing authorisation holder in Europe, Middle East and Africa.
Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2014.
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1. Edurant(R) is a registered trademark of Janssen Janssen Sciences Ireland UC.
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