(Alliance News) - GlaxoSmithKline PLC on Monday noted ViiV Healthcare's EU marketing authorisation for drug Rukobia plus other antiretrovirals to treat multidrug-resistant HIV in adults.
ViiV is majority owned by Glaxo, with Pfizer Inc and Shionogi Ltd as shareholders. It announced the European Marketing Authorisation for Rukobia, brand name for fostemsavir, 600 milligram extended-release tablets.
The EMA approval is in combination with others antiretroviral therapies, to treat multidrug-resistant HIV-1 in adults who cannot otherwise "construct a suppressive anti-viral regimen".
Fostemsavir "works by targeting the first step of the HIV lifecycle" and at present there is no -cross-resistance to other licences classes of antiretrovirals. This means the drug is a new option for people who are resistant to multiple HIV drugs and facing "risk of disease progression and death".
This authorisation was supported by data from ViiV's pivotal phase three Brighte study. In the randomised cohort, 60% of those who received fostemsavir plus an optimised background therapy, achieves undetectable HIV viral load and a clinically significant improvement to CD4+ T-cell count through week 96.
ViiV Chief Executive Deborah Waterhouse said: ""There have been great strides forward in the treatment of HIV over the last few decades, however, there still remains a small subset of people living with multi-drug resistant HIV who are at risk of having their disease progress. The marketing authorisation for fostemsavir marks a significant milestone, as it addresses a critical unmet need in HIV care for those with little or no treatment options left. At ViiV Healthcare, through our pioneering research and development, we aim to meet the diverse needs of the HIV community. We won't stop until our research offers more ways to treat, and hopefully one day, cure HIV."
Shares in Glaxo were up 1.0% at 1,279.00 pence in London on Monday afternoon.
By Anna Farley; annafarley@alliancenews.com
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