Business Wire

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Jaa

Gilead Sciences, Inc. (NASDAQ:GILD) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available. Biktarvy is the first HIV product that Gilead will launch and commercialize in Japan directly through its local subsidiary, Gilead Sciences K.K.

In the United States, Biktarvy 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 as well as the Biktarvy Indication.

The approval of Biktarvy is supported by data from four Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a diverse population of 2,415 participants on Biktarvy or an active comparator, including a wide range of adult age groups and races/ethnicities. Biktarvy met its primary objective of non-inferiority at 48 weeks across all four studies. Through 48 weeks, no participants in any of the four studies developed treatment-emergent virologic resistance while taking Biktarvy, no patients discontinued Biktarvy due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking Biktarvy were diarrhea, nausea and headache.

“Gilead is pleased that Biktarvy, our latest HIV treatment innovation, will be made available to people living with HIV in Japan,” said John McHutchison, AO, MD, Chief Scientific Officer, and Head of Research and Development, Gilead Sciences. “In multiple clinical trials, Biktarvy has demonstrated high efficacy and a high barrier to resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, it has the potential to simplify treatment initiation, and follow-up over time.”

“Gilead’s operations in Japan have expanded significantly over the years and we are pleased to now be able to bring our longstanding experience and commitment as a global leader in HIV treatment to the Japanese HIV community,” said Luc Hermans, M.D., President and Representative Director, Gilead Sciences, K.K. “Biktarvy adds an important new treatment option to our portfolio of medicines for people living with HIV in Japan.”

Biktarvy does not cure HIV infection or AIDS.

IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR BIKTARVY

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • 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 (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Biktarvy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Biktarvy. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

  • Coadministration: Do not use Biktarvy with dofetilide or rifampin.

Warnings and precautions

  • Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Biktarvy therapy and monitor for adverse reactions.
  • 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 Biktarvy, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate Biktarvy 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 Biktarvy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.

Renal monitoring: Prior to or when initiating Biktarvy and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus.

  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue Biktarvy 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 reactions (incidence ≥5%; all grades) in clinical studies through week 96 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

  • Prescribing information: Consult the full prescribing information for Biktarvy for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
  • Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of Biktarvy. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of Biktarvy. Biktarvy can increase the concentration of drugs that are substrates of OCT2 or MATE1.
  • Drugs affecting renal function: Coadministration of Biktarvy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Pregnancy and lactation

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

Dosage and administration

  • Dosage: 1 tablet taken once daily with or without food.
  • Renal impairment: Not recommended in patients with CrCl <30 mL/min.
  • Hepatic impairment: Not recommended in patients with severe hepatic impairment.
  • Prior to or when initiating: Test patients for HBV infection.
  • Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

U.S. INDICATION

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen for ≥3 months with no history of treatment failure and no known resistance to any component of Biktarvy.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

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 Biktarvy for the treatment of HIV-1 infection and the possibility of unfavorable results from additional clinical trials involving Biktarvy. 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 Annual Report on Form 10-K for the year ended December 31, 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 Biktarvy, including BOXED WARNING, is available at  www.gilead.com .

Biktarvy, Gilead and the Gilead logo are 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
+1 (650) 524-7792

Seiko Noma, Media Japan
+81-3-6837-0790

Ryan McKeel, Media US
+1 (650) 377-3548

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Immersion Signs Agreement With TDK Electronics Bringing Haptics Design and Marketing to PowerHap Piezo Actuators24.4.2019 15:30:00 EESTTiedote

Immersion Corporation (NASDAQ:IMMR), the leading developer and licensor of touch feedback technology, announced that it has signed an agreement with TDK Corp. (TSE:6762) subsidiary TDK Electronics for the design and marketing of haptic feedback for TDK PowerHap™ piezo actuators. Under the agreement, Immersion will include TDK’s actuators in reference designs for automotive, industrial and other markets. Immersion will also certify the components for use with its software products. This will enable TDK’s customers in a wide variety of markets to rapidly implement cutting-edge haptic solutions with its high-performance actuators. With 25 years in the field of touch technology, Immersion brings together the art of design and the precise science behind haptic feedback in actuators and ICs. The company connects the haptic ecosystem through the certification of haptic components, helping partners like TDK and their customers maintain consistency and high-fidelity haptic experiences across de

Kite Announces Plans for New State-of-the-Art Facility to Expand Cell Therapy Production Capabilities24.4.2019 15:30:00 EESTTiedote

Kite, a Gilead Company (Nasdaq: GILD), today announced plans for a new facility in Frederick County, Maryland, which will produce innovative cell therapies for people with cancer. The 20-acre site will significantly expand Kite’s ability to manufacture a variety of chimeric antigen receptor T (CAR T) therapies, including Yescarta® (axicabtagene ciloleucel), Kite’s first commercially available CAR T cancer therapy, and investigational T cell receptor (TCR) cell therapies being evaluated in solid tumors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190424005257/en/ “This new facility in Frederick County builds on our substantial technical capabilities and rapid progress in making personalized CAR T and TCR cell therapies for people with cancer. As we advance our industry-leading cell therapy pipeline and seek to help a growing number of people with cancer, expanding and investing in our manufacturing capabilities is essentia

SugarCRM Announces Game-Changing Product Enhancements to Accelerate Growth, Improve Business Performance and Deliver Exceptional Customer Experiences24.4.2019 15:00:00 EESTTiedote

SugarCRM Inc.®, the company that helps organizations build better business relationships, today announced several new platform capabilities to help companies to accelerate their business growth. These new capabilities will enable them to resolve customer issues quickly, collaborate more effectively, make faster and more informed decisions about their customers, eliminate time-consuming manual processes, expand real-time mobile access to critical customer information – and do all of this on the new, blazing-fast Sugar 9 platform. “With these significant enhancements, our customers can now collaborate and communicate more effectively, know more about their customers to quickly make better decisions and confidently transact more business with faster quotes, more automation and rock-solid SOC 2 compliance. Most importantly, we have boosted system performance to new heights, enabling customers to process up to 70% more transactions without investing in new hardware,” says Rich Green, chief

USD$90 Million Initiative between A*Star, Aptorum Group and Aeneas Capital to Drive Healthcare Innovations24.4.2019 15:00:00 EESTTiedote

Aptorum Group Limited (Nasdaq: APM), Aeneas Capital Limited, and A*ccelerate Technologies Pte Ltd, the enterprise office of the Agency for Science, Technology and Research (A*STAR), have signed a USD$90 million agreement to co-create local deep tech start-ups in the healthcare and life sciences sector. This agreement, is the latest in a series of venture co-creation (VCC) agreements signed by A*ccelerate to strengthen the start-up ecosystem in Singapore. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190424005535/en/ (Photo: Business Wire) Through this agreement, Aptorum Group and A*ccelerate are looking at creating up to 20 deep tech ventures in Singapore over the next five years. These enterprises will leverage technologies co-developed by A*STAR research institutes and Aptorum Group. As part of this agreement, the parties involved will also support the start-ups’ growth through actively nurturing the entrepreneurs. This w

IONITY Fast Charging Network Relies on has·to·be Know-How for the Long Term24.4.2019 13:18:00 EESTTiedote

The IONITY joint venture aims to help electromobility achieve a breakthrough in Europe with a nationwide network of super-fast charging stations. The Austrian electromobility provider, has·to·be, is playing an important role in this. The red-white-red company will take care of the reliable and trouble-free operation of the charging stations. The two companies have agreed on a long-term cooperation so that the expansion of the Europe-wide network can proceed according to plan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190424005465/en/ has·to·be and IONITY focus on long-term cooperation (Graphic: Business Wire) has·to·be, based in Radstadt (Salzburg), specializes in smart solutions for e-charging stations. For this purpose, the company has developed intelligent software for the management of electrical charging infrastructures. The product is called be.ENERGISED and is used successfully at more than 14,000 charging statio

Knopp Biosciences Receives FDA Orphan Drug Designation for Dexpramipexole for Treatment of Hypereosinophilic Syndrome24.4.2019 13:00:00 EESTTiedote

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with high unmet needs, announced today that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to dexpramipexole, its oral drug candidate for the treatment of hypereosinophilic syndrome (HES). HES is a rare and often incapacitating disorder with limited treatment options. The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose, or prevent diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees. “We are very pleased to receive orphan drug designation for dexpramipexole for HES,” said Michael Bozik, M.D., CEO of Knopp Biosc

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme