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European Medicines Agency Validates Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexually Acquired HIV

– If Approved, Truvada Would be First Antiretroviral in Europe to be Indicated for Use in Combination with Safer Sex Practices to Reduce the Risk of HIV Infection in Adults –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 1, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) announced today that the company’s Type II variation application for once-daily Truvada® (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis or PrEP, has been fully validated and is now under evaluation by the European Medicines Agency (EMA). Truvada was approved by the EMA in 2005 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and is currently the most prescribed antiretroviral treatment in Europe.

“In Europe, 2014 saw the highest number of HIV diagnoses recorded in any given year – nearly 30,000 – highlighting the substantial need for additional strategies to help address the epidemic,” said Sheena McCormack, Medical Research Council Clinical Trials Unit, University College London. “We are excited by the potential public health impact Truvada for PrEP may have, as part of a comprehensive HIV prevention strategy, in lowering transmission rates among at-risk populations across Europe.”

The application is based on the results of two large placebo-controlled trials of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the U.S. National Institutes of Health (NIH) and the University of Washington, respectively. The indication extension will be reviewed by the EMA under the centralized procedure, which, when finalized, may lead to the granting of marketing authorization by the European Commission, which is valid in all 28 member states of the European Union (EU).

In all studies of Truvada for PrEP, the most commonly reported side effects included headache, stomach discomfort and weight loss. The incidence and types of side effects were consistent with Truvada’s safety and tolerability profile when used as an HIV treatment.

“The EMA filing for Truvada for PrEP is timely given the growing body of evidence supporting its use in preventing HIV and the interest expressed by the medical and patient advocacy communities,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “Appropriate use of Truvada for PrEP is supported by European AIDS Clinical Society and World Health Organization guidelines, and Gilead believes it is an important HIV prevention tool that, when taken as directed and used in combination with other prevention strategies, has the potential to help reduce new HIV infections.”

Truvada was approved for PrEP in the United States in 2012, and in Kenya and South Africa in 2015; regulatory submissions are pending in Australia, Brazil, Canada, Peru and Thailand. Additionally, within the EU, Truvada for PrEP is currently available in France following a Temporary Recommendation for Use by the French regulatory agency (ANSM).

Truvada for PrEP is an investigational use in the EU and its safety and efficacy has not been established.
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Source: press release, 2/01/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Truvada HIV PrEPInfectious DiseaseHIV (Pre-exposure prophylaxis)Combination therapy (antiretroviral)Reverse transcriptase

Mechanism of action: Truvada ia combination of Viread (tenfovir disoproxil fumarate)and Emtriva(emtricitabine). Viread and Emtriva are both small molecules that inhibit the transcription of viral RNA into DNA by acting as nucleotide analogue reverse transcriptase inhibitors (nRTIs).

Phase of Development: Filed

Event Type: Regulatory EMA: Type II variation approval

Dates: 2016-04-29

Results:

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European CHMP Adopts Positive Opinion on Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexually Acquired HIV

– If Approved, Truvada for PrEP in Combination with Safer Sex Practices Could Offer Uninfected Adults at High Risk a New Option to Reduce the Risk of Acquiring HIV –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 22, 2016-- 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 Type II variation application for once-daily Truvada® (emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. Truvada was approved by the EMA in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.

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 (EU).

The Type II variation application is based on the results of two large placebo-controlled trials of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. In studies of Truvada for PrEP, the most commonly reported side effects included headache, stomach discomfort and weight loss. The incidence and types of side effects were consistent with Truvada’s safety and tolerability profile when used as part of an HIV treatment regimen.

“The CHMP’s opinion moves the medical community closer to being able to offer an additional HIV prevention tool to people at high risk of HIV acquisition across the entire EU,” said Professor Jean-Michel Molina, MD, PhD, Hôpital Saint Louis in Paris and University of Paris 7. “Evidence supports pre-exposure prophylaxis, in combination with safer sex practices, to reduce the risk of sexually acquired HIV and we look forward to the potential public health impact of PrEP, in addition to increasing access to testing and universal treatment of people living with the disease, in helping to lower HIV transmission rates in Europe.”

Worldwide, clinical guidelines support the use of PrEP, in combination with existing prevention measures such as condoms, to prevent the sexual transmission of HIV in adults at high risk of HIV infection. Truvada for PrEP should not be used in individuals with unknown or positive HIV-1 status, as Truvada alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking Truvada. Truvada is approved for PrEP in Australia, Canada, Kenya, Peru, South Africa and the United States. Regulatory submissions are pending in Brazil, Taiwan and Thailand. Additionally, within the EU, Truvada is currently available for PrEP in France under a Temporary Recommendation for Use by the French regulatory agency (ANSM).

The use of Truvada for PrEP is investigational in the EU and its safety and efficacy have not been established.
More
Source: press release, 7/22/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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