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GSK Says Viiv Healthcare Gets Positive CHMP Opinion For Long-acting HIV Regimen

GlaxoSmithKline plc (GSK,GSK.L) said Friday that its majority-owned specialist HIV company ViiV Healthcare has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the company's long-acting Human Immunodeficiency Virus or HIV regimen.

The CHMP positive opinion has recommended marketing authorisation for Vocabria (cabotegravir injection and tablets) in combination with Rekambys and Edurant for the treatment of HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen, without evidence of viral resistance and no prior virological failure.

The CHMP positive opinion is one of the final steps before the European Commission grants marketing authorisation.

"Today's positive CHMP opinion marks an important step in providing a new option that changes the treatment experience for people living with HIV across Europe. Vocabria injection used in combination with Rekambys has the potential to ease the day-to-day burden of HIV by offering significantly less frequent dosing from 365 days with oral regimens to 12 or 6 treatments per year," said Deborah Waterhouse, CEO of ViiV Healthcare.

Viiv Healthcare is a specialist HIV company. majority owned by GlaxoSmithKline plc or GSK, with Pfizer Inc. and Shionogi Limited as shareholders.

GlaxoSmithKline noted that if approved, cabotegravir injection in combination with rilpivirine injection will be the first complete long-acting regimen, dosed once-monthly or once every two-months, for virologically suppressed people living with HIV-1 across Europe.

This treatment will provide people living with HIV an option with significantly less frequent dosing and comparable efficacy to daily oral regimens, the company added.

The Marketing Authorisation Application for cabotegravir injection and tablets is based on the Phase III ATLAS, FLAIR and ATLAS-2M studies.

Once approved, cabotegravir injection and tablets will be marketed as Vocabria to be used with Janssen's Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets).

Health Canada has approved once-monthly dosing of cabotegravir and rilpivirine as a co-pack with two injectable medicines under the brand name Cabenuva, for the treatment of HIV-1 infection in adults who are virologically stable and suppressed, GlaxoSmithKline said.

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