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Gilead wins US approval for second TAF-based HIV drug

FDA gives Odefsey the green light

Gilead Sciences 

Gilead Sciences has added another new product to its HIV franchise following FDA approval of Odefsey, a three-drug regimen taken as a single small tablet once a day.

The new drug is a follow-up to Gilead's Complera - which contains emtricitabine, Janssen's rilpivirine and tenofovir disoproxil fumarate (TDF) - but replaces the latter with a new salt of tenofovir called tenofovir alafenamide (TAF). 

The result is a "complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per ml," according to Gilead, which notes it is also the smallest pill of any single tablet regimen on the market.

Complera is widely prescribed and has been a big success for Gilead - achieving sales of over $1.4bn last year - and the new version is expected to consolidate that position.

Gilead is in the process of replacing its TDF-based HIV products with TAF, as the new version has more than 10 times the potency of its parent and - because it can be dosed in smaller amounts - is less prone to causing renal and skeletal side effects.

Last year, Gilead was granted approval for four-drug product Genvoya (elvitegravir, emtricitabine, cobicistat and TAF), a new form of its $1.8bn Stribild brand. The company has also filed a combination of emtricitabine and TAF to sit alongside its $3.5bn Truvada product.

"As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients," said Gilead's chief executive John Martin.

The strategy provides improved therapies for patients and is also expected to help Gilead maintain its dominant position in the HIV market, currently being challenged by ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK), Pfizer and Shionogi.

Article by
Phil Taylor

2nd March 2016

From: Regulatory



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