Glaxo proposal would let HIV patients halve drugs they take
HIV patients may soon be able to take just two drugs instead of four, after a Glaxosmithkline joint venture submitted a new regimen for approval.
Viiv Healthcare said yesterday it had submitted the regimen to the European Medicines Agency, and US Food and Drug Administration for approval.
Viiv is a joint venture majorityowned by Glaxo, but also backed by US pharmaceuticals company Pfizer and Japan’s Shionogi.
The application follows a clinical trial phase that reported encouraging results, published in February.
This showed HIV-1 patients who switched to taking dolutegravir, an anti-retroviral owned by Viiv, and rilpivirine, owned by Janssen Sciences Ireland, did just as well compared with three or four-drug regimens.
Viiv is seeking approval for a singletablet treatment that carries the two separate drugs.
Glaxo cautioned in its statement: “Use of dolutegravir and rilpivirine as a two-drug regimen for HIV-1 maintenance therapy is investigational and not approved anywhere in the world.”
Glaxo also submitted a priority review voucher worth $130m with its application to the US regulators, which should mean it gets a response in around six months’ time.
In the year to the end of December, Viiv Healthcare’s profits increased to £324m from £224m in 2015. New HIV products Tivicay and Triumeq increased sales by 82pc to £2.7bn.
Deborah Waterhouse, Viiv chief executive, said: “As people living with HIV plan their lives, there is a need for new options to best manage their lifelong treatment. At Viiv Healthcare, we are not only developing potential new medicines to treat and prevent HIV infection, we are challenging the traditional HIV treatment paradigm to develop new treatment regimens.”
Glaxo’s shares ended up 2.5p at £17.06 yesterday.