ViiV redeems voucher for fast FDA review of HIV combination
ViiV Healthcare has applied for a fast US review of its single-tablet, two drug HIV drug regimen of dolutegravir and lamivudine.
The joint venture between GlaxoSmithKline, Pfizer, and Shionogi, said that it will use a priority review voucher to cut the length of the drug’s FDA review from 10 months to six months.
Trials have so far shown that the two drug combination is as effective at suppressing the disease as a commonly-used three drug combination, but with fewer side effects.
This is important for patients who have to keep taking the drugs to ensure the virus is kept at bay and does not progress to cause AIDS.
The FDA usually reserves six-month Priority Reviews for situations where there is a pressing need for a new drug for a serious or life-threatening disease.
But the FDA also hands out vouchers to companies developing drugs for children, tropical diseases or to counter national security threats, which can be sold on for other companies to use.
ViiV did not say how it acquired the priority review voucher, but last year it used the same strategy to hasten the FDA’s review of another single-tablet combination HIV therapy of Tivicay (dolutegravir) and Janssen’s Edurant (rilpivirine).
The filing for the latest combination of Tivicay and lamivudine is based on the global GEMINI 1 and 2 studies including more than 1400 HIV-1 infected patients.
The trial compared the two-drug combination with the combination of dolutegravir and a backbone of Gilead’s Truvada (fumarate/emtricitabine+tenofovir disoproxil fumarate).
ViiV filed the combination therapy with the European Medicines Agency (EMA) last month, and plans filings with other regulators in the coming months.
ViiV’s chief scientific and chief medical officer, John Pottage, said: “This [filing], if approved, will provide a single-tablet, two-drug regimen option with DTG and 3TC that we believe could have an impact on the existing HIV treatment strategy and serve as a valuable option for people living with HIV.
“ViiV Healthcare is committed to challenging the status quo with innovations that are based on our belief that no one should take more medicines than they need.”
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