CHMP Positive On Descovy, A Safer HIV Therapy?
This article was originally published in The Pink Sheet Daily
Executive Summary
Tenofovir alafenamide-based regimens could drive the growth of the anti-HIV market for next several years.
Gilead Sciences International Ltd.'s new two-drug fixed-dose HIV therapy Descovy, containing the new tenofovir prodrug tenofovir alafenamide (TAF) and emtricitabine, has received a positive opinion from Europe's top scientific advisory panel, the Committee for Medicinal Products for Human Use (CHMP), the company announced Feb. 26; Descovy is expected to be approved by the European Commission in two to three months.
Tenofovir alafenamide has exhibited high antiviral efficacy similar to and at a dose of less than one-tenth of its marketed HIV therapy Viread (tenofovir disoproxil fumarate), Gilead says. The new compound enters cells more efficiently than tenofovir disoproxil fumarate, and has also showed improvement in surrogate laboratory markers of renal and bone safety compared with Viread in clinical trials in combination with other antiretroviral agents, the company adds.
Analysts at Informa's Datamonitor Healthcare said that launches of tenofovir alafenamide-based regimens, with their improved safety profiles, and the increasing prevalence of HIV infections, will drive the growth of the anti-HIV market until 2022. However, pressure will gradually increase on physicians to use less expensive single-component generics as patents start to expire on originator compounds, they added.
The CHMP concurred with Gilead on the safety of Descovy: "The most common side effect is nausea. Descovy has low impact on renal safety and bone mineral density compared with tenofovir disoproxil," the committee said in its opinion summary. "Descovy is an alternative treatment option to the licensed tenofovir disoproxil and is expected to have similar efficacy," it added. Descovy will be marketed at two doses: emtricitabine 200mg/tenofovir alafenamide 10mg, and 200mg/25mg.
The marketing application was supported by two pivotal 48-week Phase III trials (Studies 104 and 111) in which a tenofovir alafenamide-containing regimen met its primary endpoint of non-inferiority compared with a tenofovir disoproxil containing regimen.
In the US, the combination product has a user fee date of April 7, according to "The Pink Sheet" FDA Performance Tracker (Also see "User Fee Goal Dates" - Pink Sheet, 16 Nov, 2015.).
Gilead's Genvoya Approved Last November
The European Commission approved the first of Gilead's new HIV therapies containing tenofovir alafenamide in November 2015. Genvoya is a once-daily single tablet containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide for the treatment of HIV-1 infection. It is an alternative formulation to Gilead's marketed HIV-1 Stribild that contains the tenofovir disoproxil fumarate component. A third product has also been filed for approval by Gilead in Europe, a once-daily single-tablet regimen of emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine (from Janssen).
Genvoya was also approved for marketing in the US in November 2015, and the emtricitabine plus tenofovir alafenamide combination has been filed for approval there, with a PDUFA date of Apr. 7
The use of tenofovir alafenamide has not been universally welcomed, with AIDS activists complaining that the new component for HIV therapies prolongs patent protection on tenofovir that was due to expire in 2018, and have questioned Gilead's decision not to market tenofovir alafenamide as a stand-alone product (Also see "Gilead's Pricing Strategy Faces New Opposition Tactics: Patent, Antitrust Suit" - Pink Sheet, 27 Jan, 2016.).
[Editor's note: This story is also published in Scrip Intelligence. "The Pink Sheet" DAILY brings selected complementary coverage from sister publications to subscribers.]