Therapy Areas: AIDS & HIV
CHMP Issues Janssen Positive Opinion for Juluca (dolutegravir/rilpivirine)
27 March 2018 - - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued Janssen Pharmaceutical Companies, a segment of US-based global healthcare company Johnson and Johnson (NYSE: JNJ), a positive opinion recommending marketing authorisation for Juluca (dolutegravir 50mg/rilpivirine 25mg, the company said.
Dolutegravir/rilpivirine is a single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).
Dolutegravir/rilpivirine maintains the efficacy of a traditional three-drug regimen with only two antiretrovirals.
The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorisation for medicines in the European economic area. The EC's final decision is anticipated during the second quarter of 2018.
Dolutegravir/rilpivirine is a two-drug regimen, once-daily, single-pill that combines the INSTI dolutegravir, with the NNRTI rilpivirine taken once-daily as a complete HIV regimen for people living with HIV who are virologically suppressed.
The SWORD phase 3 programme evaluates the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four-drug regimen.
The Janssen Pharmaceutical Companies of Johnson and Johnson work to find new and better ways to prevent, intercept, treat, and cure disease. The pharmaceutical segment offers various products in the areas of immunology, infectious diseases and vaccines, neuroscience, oncology, and cardiovascular and metabolic diseases.
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