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GSK company wins European panel approval for two-drug HIV treatment
GlaxoSmithKline's specialist HIV company ViiV Healthcare won approval from the European Medicines Agency for its two drug regimen to treat the AIDS causing disease.
The Juluca drug combination, which is aimed at reducing side effects suffered by patients who use current treatments comprised of combinations of three or four drugs, was backed by The Committee for Medicinal Products for Human Use (CHMP).
Deborah Waterhouse, chief executive of ViiV Healthcare, said: "Today is an important milestone for people living with HIV in Europe. It takes us a step closer to offering the first, single-pill, 2-drug regimen with the opportunity to reduce the number of drugs needed to treat HIV in those who are virologically suppressed; Juluca is expected to be the smallest single-pill regimen in the market."
Juluca is a fixed dose once daily tablet that combines previously approved drugs dolutegravir and rilpivirine and is suitable for patients who have been on a stable regimen for six months.
The combination was approved by the US Food and Drug Administration in November and the CHMP judgement is a sign of likely approval by the European Commission in the second quarter of 2018.
An estimated 36.7m people live with HIV, including 160,000 sufferers who were newly diagnosed in Europe within 2016.
"ViiV Healthcare is committed to delivering advances in HIV care, including providing innovative treatment options that meet the evolving needs of people living with HIV and we are willing to challenge the traditional HIV treatment paradigms to deliver these advances," said Waterhouse.
Brentford based ViiV Healthcare is majority-owned by GlaxoSmithKline with Pfizer and Shionogi also holding small stakes in the company.
As of 1526 BST, GlaxoSmithKline's shares were up 4.97% at 1352.20p.