European Commission grants Marketing Authorization for Gilead’s Biktarvy® (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection
– In clinical trials, Biktarvy demonstrated high efficacy and zero resistance through 48 weeks –
FOSTER CITY, Calif., Jun. 25, 2018– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the European Commission has granted Marketing Authorization for Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF), a guidelines-recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone. Today’s decision makes BIC/FTC/TAF Gilead’s third FTC/TAF-based STR approved in the European Union in the past three years.
In Europe, BIC/FTC/TAF is indicated as a complete regimen for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. No dosage adjustment of BIC/FTC/TAF is required in patients with estimated creatinine clearance (CrCL) greater than or equal to 30 mL per minute. BIC/FTC/TAF has convenient dosing, does not require testing for HLA-B 5701, and has no food intake or baseline viral load or CD4 count restrictions.
“To help support the long-term health of people living with HIV, it is crucial to have regimens that deliver durable viral suppression with a high barrier to resistance,” said Professor Alan Winston, Professor of HIV and Genitourinary Medicine at Imperial College and Consultant Physician at St. Mary’s Hospital, London, UK. “In clinical trials through 48 weeks, BIC/FTC/TAF has shown high efficacy and zero 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.”
Today’s decision is supported by data from four ongoing 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 population of 2,415 participants. BIC/FTC/TAF met its primary objective at 48 weeks in all four studies.
Through 48 weeks, no participants in any of the four studies failed BIC/FTC/TAF with treatment-emergent virologic resistance, no participants discontinued BIC/FTC/TAF 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 BIC/FTC/TAF were diarrhea, nausea and headache.
“We are pleased to offer BIC/FTC/TAF, the latest innovation in our comprehensive HIV research and development program, which encompasses prevention, treatment and cure,” said Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences. “The approval of BIC/FTC/TAF demonstrates our continued commitment to improving care for people living with HIV, and we look forward to working with health authorities across Europe to ensure that BIC/FTC/TAF is made widely available as soon as possible.”
Additional studies not included in the marketing authorization application are also ongoing, including dedicated studies in women, and in adolescents and children.
BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018.
About Gilead Sciences, Inc.
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 nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Today, it’s estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s generic manufacturing partners.
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 BIC/FTC/TAF for the treatment of HIV-1 infection and the possibility of unfavorable results from additional clinical trials involving BIC/FTC/TAF. 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 March 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.
Full European Summary of Product Characteristics for Biktarvy and Descovy are available from the EMA website at www.ema.europa.eu.
Biktarvy, Descovy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.