11th Dec 2020 14:25
(Alliance News) - ViiV Healthcare, an HIV specialist company majority owned by GlaxoSmithKline PLC, said an EU committee has issued a positive opinion recommending approval of Rukobia extended release tablets as a treatment for of HIV-1 infection.
ViiV is an HIV specialist company, majority owned by pharmaceutical firm Glaxo but with Pfizer Corp and Shionogi Ltd as shareholders. Shares in Glaxo were up 0.3% at 1,422.00 pence in London on Friday afternoon.
The positive opinion was issued by the European Medicines Agency's Committee for Medicinal Products for Human Use and is for 600 milligram extended-release tablets of Rukobia, the brand name for fostemsavir.
ViiV said: "Fostemsavir, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen."
ViiV's marketing authorisation application for fostemsavir is supported by data from its phase 3 Brighte study and final marketing authorisation from the European Commission is expected in the coming months, following US approval in July.
Additional regulatory applications have been submitted worldwide.
Deborah Waterhouse, chief executive of ViiV Healthcare, said: "While incredible strides have been made in treating HIV over the past few decades, a select population of adults with multidrug resistant HIV-1 infections are not able to maintain viral suppression with currently available medication. Without effective new options, this group of people are at risk of progressing to AIDS, so a positive opinion from the CHMP for fostemsavir, is extremely welcome news and is an important step towards ensuring no one is left behind at any stage of living with HIV.
"We are committed to pursuing innovative research to meet the diverse needs of the HIV community, and this positive CHMP opinion comes from the culmination of complex research, development and manufacturing. We won't stop until we have more ways to treat, and hopefully one day cure, HIV."
Earlier on Friday, Glaxo and Sanofi SA said their Covid-19 vaccine has been delayed to the end of 2021 after interim study result found an insufficient response in older patients.
The phase 1/2 study's interim results showed an immune response that was comparable to patients who had recovered from Covid-19 in adults aged 18 to 49, but a low immune response in older adults.
The two firms plan to begin a phase 2b study in February 2021 with an improved antigen formulation, which will include a proposed comparison with an already authorised Covid-19 vaccine.
With positive data, a global phase 3 study could begin in the second 2021 quarter, and positive results from that would lead to regulatory submissions in the second half of 2021.
Overall, this means the vaccine potential availability has moved to the fourth 2021 quarter from the mid-2021 initial target.
By Anna Farley; [email protected]
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