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In addition to R/F/TAF, two other MAAs for TAF-based regimens are under review by the EMA. The MAA for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF) was fully validated on December 23, 2014. The MAA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) was fully validated on May 28, 2015. Gilead has submitted New Drug Applications to the U.S. Food and Drug Administration for E/C/F/TAF, F/TAF and R/F/TAF on November 5, 2014, April 7, 2015, and July 1, 2015, respectively.
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Source: press release, 8/20/15. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Elvitegravir/Cobicistat/Emtricitabine/TAF combination (E/C/F/TAF)Infectious DiseaseHuman Immunodeficiency Virus (HIV)Combination therapy (antiretroviral)Various HIV

Mechanism of action: Elvitegravir (GS-9137), a SM-inhibitor, interferes with the transfer of the viral genome into the host genome via inhibition of the integrase enzyme. Cobicistat (GS-9350)is a pharmacokinetic enhancer, is a potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Tenofovir alafenamide (TAF) (GS-7340), a SM, nucleotide analogue reverse transcriptase inhibitor (nRTI). Emtricitabine is a small molecules that inhibit the transcription of viral RNA into DNA by acting as a nucleotide analogue reverse transcriptase inhibitor (nRTI). Tenofovir alafenamide inhibits the transcription of viral RNA into DNA. It is a novel prodrug of tenofovir.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2015-11-20

Results:

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European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection
– Gilead’s First TAF-based Single Tablet Regimen Demonstrates High Efficacy with Improved Renal and Bone Parameters Compared to TDF-based Regimens –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 23, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for the once-daily single tablet regimen Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive marketing authorization in the European Union (EU).

Genvoya is indicated in the EU for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

“With access to appropriate treatment, HIV patients today have the potential to live nearly as long as the general population. However, research shows they are at an increased risk of age- and treatment-related comorbidities, which means helping preserve long-term health should be a priority when making treatment decisions,” said Anton Pozniak, HIV Service Director, Chelsea and Westminster Hospital, London, UK. “With Genvoya, we have an important new treatment option for a range of HIV patients, as it offers both demonstrated sustained viral suppression and improvements in renal and bone safety markers compared to TDF-based regimens.”

Photos and multimedia gallery available at www.GileadHIVEU.com.

Today’s marketing authorization is based on a Phase 3 HIV clinical program in more than 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients. It allows for the marketing of Genvoya in all 28 countries of the EU.

TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a lower dose resulting in 91 percent less tenofovir in the bloodstream.

“For more than 25 years, Gilead has continually worked to develop new treatments to improve the management of HIV,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “Genvoya, along with other investigational products in our TAF-based portfolio, have the potential to deliver long-term health benefits to people living with HIV across Europe and around the world.”

The marketing authorization is supported by 48-week data from two ongoing Phase 3 studies (Studies 104 and 111) among 1,733 treatment-naïve adult patients in which the regimen met its primary endpoint of non-inferiority compared to Stribild® (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF). In the combined analysis of the studies, 92.4 percent of Genvoya patients and 90.4 percent of Stribild patients had HIV-1 RNA levels less than 50 copies/mL at Week 48. Certain renal and bone laboratory parameters favored Genvoya over Stribild.

Additionally, the approval is supported by a Phase 3 study (Study 109) among virologically suppressed adult patients who were randomized either to stay on their TDF-based regimen or switch to Genvoya. The study enrolled 1,436 subjects. At Week 48, switching to Genvoya was found to be statistically superior to remaining on TDF-based regimens based on the percentages of patients with HIV-1 RNA levels less than 50 copies/mL. Patients receiving Genvoya also demonstrated improvements in certain bone and renal laboratory parameters compared to those who stayed on their TDF-based baseline regimen. Finally, data from two studies evaluating Genvoya among treatment-naïve adolescents and among virologically suppressed adult patients with mild-to-moderate renal impairment (eGFR between 30-69ml/min) supported the approval.

For important safety information for Genvoya, including contraindications, special warnings, drug interactions, and adverse drug reactions, please see the European SmPC for Genvoya, available from the EMA website at www.ema.europa.eu.

In addition to Genvoya, two other TAF-based regimens are currently under evaluation by the EMA. The first is an investigational, fixed-dose combination of emtricitabine 200 mg and tenofovir alafenamide 25 or 10 mg (F/TAF) for use in combination with other antiretroviral agents. The second is an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg (R/F/TAF). Emtricitabine and tenofovir alafenamide are from Gilead and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

F/TAF and R/F/TAF are investigational products and their efficacy and safety have yet not been established in the European Union.
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Source: press release, 11/23/15. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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European CHMP Adopts Positive Opinion for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV
– Gilead’s First TAF-based Regimen to Receive CHMP Positive Opinion –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 25, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for the investigational, once-daily single tablet regimen Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg) for the treatment of HIV-1 infection. The data submitted in the MAA support the use of the regimen among adult and adolescent treatment-naïve individuals, virologically suppressed adults who switch regimens and adults with mild-to-moderate renal impairment.

The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. If authorized, Genvoya would be Gilead’s first single tablet regimen to contain TAF.

TAF is a novel investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents.

The MAA for Genvoya is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the regimen met its primary objective of non-inferiority compared to Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-naïve adult patients. In the studies, Genvoya demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to Stribild. The MAA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among adolescents, virologically suppressed adult patients who switched to Genvoya and adult patients with mild-to-moderate renal impairment.

In addition to Genvoya, two other TAF-based regimens are currently under evaluation by the EMA. The first is an investigational, fixed-dose combination of emtricitabine 200 mg and tenofovir alafenamide 25 or 10 mg (F/TAF) for use in combination with other antiretroviral agents. The second is an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg (R/F/TAF). Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

TAF and all TAF-based regimens are investigational products and their safety and efficacy have not been established in the European Union.
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Source: press release, 9/25/15. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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