Did Gilead Sciences skirt an FDA rejection by tweaking combo pill ingredient?
A November 2015 article on BusinessWire.com stated that, following the recent U.S. Food and Drug Administration approval of the HIV/AIDS pill Genvoya, AIDS Healthcare Foundation (AHF), the largest global AIDS organization, questioned the full spectrum of the drug company’s motives with its newest HIV/AIDS treatment.
Genvoya is an updated four-in-one combination treatment based on drugmaker Gilead Sciences’ own earlier treatment known as Stribild.
“We believe Gilead’s petition was wholly unjustified and we filed an official comment with FDA at the time in 2013 challenging Gilead’s request,” AHF said according to the website.
The Business Wire article quoted AHF President Michael Weinstein: “By all means, news that an alternate form of tenofovir in Genvoya is less likely to cause kidney damage or bone loss in patients is welcome; however, we believe that Gilead’s updated four-in-one combination was also developed as a means to do an end run and extend the prior patent on Stribild with this updated, but essentially similar combination therapy.”
“In 2013, Gilead unsuccessfully petitioned the FDA for a patent extension for five years of exclusivity on Stribild—which at $28,500 per patient per year when it was introduced in January 2013 was the most expensive fixed-dose first-line combination therapy on the market. We believed then—as now—that Gilead was trying to monopolize the market by price gouging on its HIV/AIDS treatments, actions that severely diminish access to these lifesaving medications,” Weinstein added.
The New York Times says about Genvoya: “[It] contains the same four drugs as Stribild, but with the tenofovir disoproxil fumarate replaced by tenofovir alafenamide. The new form of the inhibitor, Gilead said, enters cells where HIV replicates more efficiently, resulting in 91 percent less tenofovir in the bloodstream. That should make the pill less likely to cause kidney damage or loss of bone density…”
Also in response to the FDA’s approval of Gilead’s Genvoya, the Indian online news site “The Hindu” published a November 8, 2015 article titled, ‘Magic Pill, or Just an Old Cocktail?’ In it, the author wrote, “There are two things one needs to know about this drug. First, it is not a new drug. It is a combination of four old drugs — elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (TAF). This is called a Fixed Dose Combination (FDC).
The company’s marketing application in Europe was supported by two late-stage studies that showed fewer adverse effects than Stribild over 48 weeks of treatment.
In January 2013, shortly after the FDA approved Stribild, the FDC upon which Genvoya is now based, Gilead filed a petition with the FDA seeking an extension on its patent protection on Stribild from three years to five years.
“While we are happy to have an updated fixed-dose therapy that may be less likely to cause harmful side-effects in patients, we also will explore patent issues around Genvoya and will certainly oppose any move by Gilead to seek any additional patent extension or protection on Genvoya as it did with Stribild,” said AHF’s Weinstein.
Stribild raked in sales of $803 million for Gilead in the first half of 2015, according to a regulatory filing from the company.