15:42, June 09 200 0

2017-06-09 15:42:05

 

FDA approves generic Truvada in surprise decision

The blockbuster announcement — long thought to be expected sometime in 2021 — took advocates for the HIV community by surprise: the Food and Drug Administration on Friday approved a generic version of Gilead Science’s antiretroviral tenofovir disoproxil fumarate/emtricitabine — commonly known as Truvada.

“Yes, the first generic for Truvada has been approved and will now be available in the U.S.,” Jeffrey S. Murray, MD, MPH, deputy director of the Division of Anti-Viral Products at the FDA, told POZ. “Usually, it takes several generics before full cost-savings potential is reached though. Hopefully, this will help to expand PrEP availability for many.”

Poz reported the company chosen by the FDA the right to produce generic Truvada is Teva Pharmaceuticals. A spokesperson for Teva confirmed the company received approval, but had nothing to add.

The fixed-dose combination tablet, like its brand-name version, is to be used as a component of an HIV treatment regimen and as pre-exposure prophylaxis or PrEP. The only difference between the generic and Truvada will be the cost and reportedly a variation on its famous powder-blue color.

What remains unclear is what exclusivity the FDA is giving Teva to produce generic Truvada. In most cases, manufacturers of generic products often hold exclusive rights for a determined period before competitors are permitted to produce their own versions that in turn drive down prices.

Murray told Poz that determination may be several months away.

“While this is stunning news that AIDS activists didn’t expect until 2021, I’m worried about the fallout,” ACT UP and Treatment Action Group veteran Peter Staley told Poz. “Gilead’s patient and copay assistance programs have become central pillars in patient access. They must maintain these programs, and Teva must establish equivalent or better assistance programs for their generic version.”


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