Business Wire

China National Medical Products Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection

Del

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the China National Medical Products Administration (NMPA) has approved Descovy® (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. In China, Descovy is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged 12 years and older with body weight at least 35 kg).

In the United States, Descovy has a boxed warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B. See below for U.S. important safety information, indication, and limitations of use.

TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s TDF (tenofovir disoproxil fumarate 300 mg) but at one-tenth of the dose. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to peripheral blood mononuclear cells compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. In clinical trials, TAF demonstrated improved renal and bone laboratory safety parameters compared to TDF.

“Advances in HIV therapies have changed the way physicians think about long-term care. As the number of people aging with HIV continues to grow, it is critical that treatments are designed to help address evolving health needs,” said Professor Li Taisheng, Peking Union Medical College Hospital. “As an effective HIV treatment backbone with a demonstrated renal and bone safety profile, Descovy may help support the long-term needs of a range of appropriate patients living with HIV.”

In 2017, there were 134,512 people newly diagnosed with HIV in China. The number of diagnoses has increased significantly in recent years, partially due to expanded screening. At the same time, the number of people living with HIV and receiving antiretroviral treatment has also increased steadily. The government of China has provided free antiretroviral treatment to all persons living with HIV since 2003.

“With this approval, Descovy joins Genvoya® as another TAF-based treatment option available in China to help address the needs of people living with HIV,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “The components of Descovy, used together with other antiretroviral agents as part of either a single or multi tablet regimen, offer physicians and patients an effective treatment combination that has the potential to improve health.”

The approval of Descovy is supported by 144-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the F/TAF-based regimen (administered as Genvoya; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) met its primary objective of non-inferiority compared to an F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, E/C/F/TDF) among treatment naïve adult patients. Tests of certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen.

The approval also is supported by a Phase 3 study (Study 109) evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adult patients who switched from F/TDF-based regimens. In the study, the F/TAF-based regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens. Additionally, the approval is supported by data from Phase 3 studies evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adults with mild-to-moderate renal impairment and among treatment naïve adolescents.

Descovy received marketing approval from the U.S. Food and Drug Administration (FDA) and the European Commission in 2016. In the U.S., only the emtricitabine 200 mg/tenofovir alafenamide 25 mg dosage form is approved.

Descovy does not cure HIV infection or AIDS.

U.S. Important Safety Information for Descovy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Descovy is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Descovy have not been established in patients coinfected with HIV-1 and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Descovy. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Descovy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Warnings and precautions

  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
  • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of emtricitabine and tenofovir alafenamide with elvitegravir and cobicistat, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate Descovy in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Descovy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
    Renal monitoring: In all patients, monitor CrCl, urine glucose, and urine protein prior to initiating and during therapy. In patients with chronic kidney disease, additionally monitor serum phosphorus.
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including emtricitabine and TDF. Discontinue Descovy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

  • Most common adverse reaction (incidence ≥10%; all grades) in clinical studies was nausea (10%).

Drug interactions

  • Prescribing information: Consult the full prescribing information for Descovy for more information on potentially significant drug interactions, including clinical comments.
  • Metabolism: Drugs that inhibit P-gp can increase the concentrations of components of Descovy. Drugs that induce P-gp can decrease the concentrations of components of Descovy, which may lead to loss of efficacy and development of resistance.
  • Drugs affecting renal function: Coadministration of Descovy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and tenofovir and the risk of adverse reactions.

Dosage and administration

  • Dosage: Patients weighing at least 35 kg: 1 tablet taken orally once daily with or without food.
  • Renal impairment: Not recommended in patients with CrCl <30 mL/min.
  • Testing prior to initiation: Test patients for HBV infection and assess CrCl, urine glucose and urine protein.

Pregnancy and lactation

  • Pregnancy: There is insufficient human data on the use of Descovy during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established; available data from the APR for emtricitabine shows no difference in the rates of birth defects compared with a U.S. reference population.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

U.S. Indication for Descovy

Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients weighing at least 35 kg.

Limitations of Use:

Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV-1 infection.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing Descovy for the treatment of HIV-1 infection and the possibility of unfavorable results from ongoing and additional clinical trials involving Descovy. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full Prescribing Information for Descovy, Genvoya, and Stribild, including BOXED WARNINGS is available at www.gilead.com .

Descovy, Genvoya, and Stribild are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact information

Sung Lee, Investors
(650) 524-7792

Sonia Choi, Media
(650) 425-5483

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

The Posiflex Group Showcases an Ecosystem of Connected Solution Endpoints with IoT Remote Monitoring at Computex 201924.5.2019 01:00:00 CESTPressemelding

For the Computex 2019 show, The Posiflex Group is featuring leading solution technology from the family of brands as a fully Serviced IoT Ecosystem. Solution end points include: Connected Modular Kiosks, POS Terminals, and Digital Signage solutions from Posiflex and KIOSK Information Systems Smart Medical Displays with gesture controls from Portwell Connected Gaming Solutions with Player Tracking Technology from Portwell subsidiary, Ganlot The booth display is based on common field service endpoints represented in a European Manor Destination Resort setting. Field solutions for an array of vertical market applications include QSR ordering, cinema ticketing, fashion retail customer loyalty, interactive signage, hotel / medical center check-in and bill pay, as well as casino gaming technology. This year, in addition to their renowned POS product suite, Posiflex will be featuring newly introduced Modular Kiosk platforms (co-designed by KIOSK and Posiflex), which are configure-to-order sta

Audi China President Thomas Owsianski to Keynote at CES Asia 201923.5.2019 20:00:00 CESTPressemelding

The Consumer Technology Association (CTA)TM today announced that Thomas Owsianski, president of Audi China, will deliver a keynote address at the upcoming CES Asia 2019. Now in its fifth year, CES Asia will run June 11-13, 2019 at the Shanghai New International Expo Centre (SNIEC) in Shanghai, China. Thomas Owsianski’s keynote is scheduled for 4 PM, Tuesday, June 11, where he will unveil Audi’s vision in transforming mobility from a driving experience to a digital adventure. Mr. Owsianski joined the top management team of Audi China in August 2018 and was named President in October 2018. “Audi has been at the forefront of driving global transformation in the automotive industry through their breakthrough advancements in technology,” said Karen Chupka, executive vice president, CES. “Innovation has revolutionized the transportation experience, and we welcome Mr. Owsianski to the CES Asia stage to share Audi’s vision for the future of global mobility.” Throughout Asia and beyond, technol

ITechLaw Publishes New Book and Opens Global Public Comment Period on Draft Principles for Responsible Artificial Intelligence23.5.2019 19:11:00 CESTPressemelding

The International Technology Law Association (ITechLaw) has published Responsible AI: A Global Policy Framework, a new book that provides an in-depth review and eight discussion principles that address some of the hottest technology and moral issues of responsible development, deployment and use of artificial intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190523005752/en/ ITechLaw releases new book, Responsible AI: A Global Policy Framework, and opens public comment period. (Photo: Business Wire) Written by a multi-disciplinary group of 54 technology law experts, industry representatives and researchers from 16 countries, the book offers an actionable framework built on the following principles: Ethical Purpose and Societal Benefit, Accountability, Transparency and Explainability, Fairness and Non-discrimination, Safety and Reliability, Open Data and Fair Competition, Privacy, and AI and Intellectual Property.

Kumulus Vape, the 100% Online E-Cigarette Specialist, Goes Public23.5.2019 16:49:00 CESTPressemelding

Kumulus Vape (ISIN FR0013419876 – MLVAP ), an online retailer specialised in the sale of electronic cigarettes and related products (devices, e-liquid and accessories), referred collectively as “e-cigarettes”, is pleased to announce the listing of its shares on the Euronext Access™ compartment in Paris by technical admission (Euronext notice PAR_20190523_05573_ACC). First listing will take place on 28 May 2019. This initial public offering - a first in Europe’s e-cigarette space - is a new milestone in the performance trajectory of the Lyon-based company, a pioneer on this market in acceleration phase. Kumulus Vape posted 2018 sales of €6.5 million, up 116% on 2017. Its outlook is highly auspicious, with 96% quarter-on-quarter growth in the first quarter of 2019. Kumulus Vape’s goal is clear: to become one of the French leaders in 100% online e-cigarette retail within three years. AN E-CIGARETTE PIONEER A CATALOGUE OF OVER 6,000 REFERENCES Kumulus Vape is one of the top online French r

Andersen Global Expands UK Locations23.5.2019 13:30:00 CESTPressemelding

Claritas Tax Limited, a Birmingham, United Kingdom-based collaborating firm of Andersen Global, has opened a new office location in Deansgate, Manchester city center. This means that Andersen Global now has a presence in six locations in the UK through its member firms and collaborating firms. “Now more than ever, it’s important that businesses have easy access to quality advice in the UK’s dynamic political and business environment. The addition of another location in the region adds to our existing capabilities and will allow us to continue providing best-in-class service,” said Mark Vorsatz, Andersen Global Chairman and CEO of Andersen Tax LLC. Founded in 2012, Claritas Tax Limited has a list of clientele from entrepreneurial, privately owned, venture capital, and private equity owned businesses, listed companies and stakeholders. Claritas provides a broad range of tax consulting services, including all aspects of M&A and transactional taxes, R&D and Intellectual Property claims, sh

Mindbreeze Receives Attestation in Accordance with BSI Cloud Requirements23.5.2019 13:11:00 CESTPressemelding

Mindbreeze receives attestation for its Mindbreeze InSpire SaaS service according to the specifications of the C5 catalogue of requirements (Cloud Computing Compliance Controls Catalogue, abbreviated C5), published by the German Federal Office for Information Security (BSI). The Mindbreeze InSpire SaaS service is professionally operated in Mindbreeze data centers on behalf of the customers. The attestation was issued by KPMG Alpen-Treuhand GmbH Wirtschaftsprüfungs- und Steuerberatungsgesellschaft. “The number of cloud services in the field of data analysis is growing steadily. This makes it all the more essential for customers to take a closer look at the choice of suppliers. C5 provides the regulatorily defined IT security level, which is comparable to the IT basic protection level that is increased by cloud controls,” explains Klaus Schatz, Managing Director of KPMG Advisory GmbH. C5 attestation (ISAE 3000 Report Type 2) is a recognized and authoritative verification for all customer