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GlaxoSmithKline's ViiV gets EU authorisation for complete HIV treatment
21st Dec 2020 08:08
(Sharecast News) - GlaxoSmithKline announced on Monday that its majority-owned HIV-specialist ViiV Healthcare had received marketing authorisation for the first complete, long-acting injectable HIV treatment in Europe.
The FTSE 100 company said ViiV, which it co-owns with Pfizer and Shionogi, had received approval for 'Vocabria', or cabotegravir injection and tablets, in combination with Johnson & Johnson's 'Rekambys', or rilpivirine injection, and 'Edurant', or rilpivirine tablets, in the European Union for the treatment of HIV-1 infection in adults who were virologically suppressed.
It said cabotegravir injection was indicated, in combination with rilpivirine injection, for the treatment of HIV-1 infection in adults who were virologically suppressed on a stable antiretroviral regimen, without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.
The authorisation represented the first time people living with HIV in Europe would be able to receive a long-acting injectable treatment that removed the need to take daily oral tablets, following the oral initiation phase, GSK claimed.
It said the largest global HIV patient-reported outcomes study to date conducted by ViiV Healthcare, 'Positive Perspectives Wave 2', found that when participants were asked about their treatment aspirations and attitudes towards innovative medications, 55% would prefer not having to take medication daily, as long as their HIV stayed suppressed.
In addition, 58% noted that taking daily HIV medication acted as a constant reminder of HIV in their lives, while up to 38% of participants reported anxiety around the fact that taking daily treatment could increase the chances of revealing their HIV status to others.
"At ViiV Healthcare, we push the boundaries to provide new treatment options that will help make a difference to people's lives," said ViiV Healthcare chief executive officer Deborah Waterhouse.
"We saw from the patient reported outcomes in our pivotal clinical trials that approximately nine out of 10 people who switched to the long-acting regimen preferred this over their previous daily oral tablets.
"It will potentially change the treatment experience for some people living with HIV by removing the need for daily HIV tablets."
GSK said the marketing authorisation was based on the pivotal phase 3 'ATLAS', 'FLAIR' and 'ATLAS-2M' studies, which included more than 1,200 participants from 16 countries.
It said cabotegravir and rilpivirine are co-administered as two intramuscular injections in the buttocks by a healthcare professional at the same appointment.
At 0842 GMT, shares in GlaxoSmithKline were up 1.33% at 1,374.4p.
The FTSE 100 company said ViiV, which it co-owns with Pfizer and Shionogi, had received approval for 'Vocabria', or cabotegravir injection and tablets, in combination with Johnson & Johnson's 'Rekambys', or rilpivirine injection, and 'Edurant', or rilpivirine tablets, in the European Union for the treatment of HIV-1 infection in adults who were virologically suppressed.
It said cabotegravir injection was indicated, in combination with rilpivirine injection, for the treatment of HIV-1 infection in adults who were virologically suppressed on a stable antiretroviral regimen, without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.
The authorisation represented the first time people living with HIV in Europe would be able to receive a long-acting injectable treatment that removed the need to take daily oral tablets, following the oral initiation phase, GSK claimed.
It said the largest global HIV patient-reported outcomes study to date conducted by ViiV Healthcare, 'Positive Perspectives Wave 2', found that when participants were asked about their treatment aspirations and attitudes towards innovative medications, 55% would prefer not having to take medication daily, as long as their HIV stayed suppressed.
In addition, 58% noted that taking daily HIV medication acted as a constant reminder of HIV in their lives, while up to 38% of participants reported anxiety around the fact that taking daily treatment could increase the chances of revealing their HIV status to others.
"At ViiV Healthcare, we push the boundaries to provide new treatment options that will help make a difference to people's lives," said ViiV Healthcare chief executive officer Deborah Waterhouse.
"We saw from the patient reported outcomes in our pivotal clinical trials that approximately nine out of 10 people who switched to the long-acting regimen preferred this over their previous daily oral tablets.
"It will potentially change the treatment experience for some people living with HIV by removing the need for daily HIV tablets."
GSK said the marketing authorisation was based on the pivotal phase 3 'ATLAS', 'FLAIR' and 'ATLAS-2M' studies, which included more than 1,200 participants from 16 countries.
It said cabotegravir and rilpivirine are co-administered as two intramuscular injections in the buttocks by a healthcare professional at the same appointment.
At 0842 GMT, shares in GlaxoSmithKline were up 1.33% at 1,374.4p.