Business Wire

U.S. Food and Drug Administration Approves Gilead’s Vosevi™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus

Del

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vosevi™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies, which evaluated 12 weeks of Vosevi in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

“Direct-acting antiviral regimens have transformed HCV treatment and have allowed health care providers the fortunate opportunity to cure many patients. However, for patients who require re-treatment, there remains an unmet clinical need for an effective and well-tolerated option,” said Ira Jacobson, MD, Chairman of the Department of Medicine at Mount Sinai Beth Israel, New York City and a principal investigator in the Vosevi clinical trials. “Treatment with Vosevi resulted in high cure rates in clinical studies of patients who were not previously cured with several widely-prescribed DAA regimens and will provide physicians with an important new therapeutic option that could offer hope for their hardest-to-treat patients.”

Vosevi has a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients. See below for important safety information.

Vosevi is the latest single-tablet regimen in Gilead’s portfolio of sofosbuvir-based DAA treatments that offer people living with HCV a short course of therapy to cure their HCV, with the convenience associated with once-daily single-tablet regimens. Since 2013, Gilead has brought to market four HCV treatments, including 3 single-table regimens. To date, more than an estimated 1.4 million patients worldwide have been treated with sofosbuvir-based regimens.

“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “The approval of Vosevi completes our portfolio by fulfilling the unmet need for an effective regimen for patients who could not be cured, despite prior treatment with certain DAA regimens.”

The approval of Vosevi is supported by data from the POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis who had failed prior treatment with an NS5A inhibitor-containing regimen, as well as data from the POLARIS-4 study evaluating 12 weeks of treatment among adults with HCV genotypes 1a and 3 with or without compensated cirrhosis who had failed prior treatment with a sofosbuvir-containing regimen that did not include an NS5A inhibitor. In these populations across the two studies, 340 of the 353 patients treated with Vosevi (96 percent) achieved the primary endpoint of SVR12, defined as maintaining undetectable viral load 12 weeks after completing therapy.

The most common adverse events (≥10% of patients) among patients who received Vosevi were headache, fatigue, diarrhea and nausea. The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2% for subjects who received Vosevi for 12 weeks.

U.S. Patient Support Program

To support these patients and their families, Gilead’s U.S. Support Path® program provides information regarding access and reimbursement coverage options to patients in the United States who need assistance with coverage for their Gilead HCV medications, including Vosevi. Support Path conducts benefits investigations and provides patients with information regarding their insurance options.

Further, the Vosevi Co-pay Coupon Program offers co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs.

To learn more about Support Path for Vosevi, please visit www.MySupportPath.com or call 1-855-7-MYPATH (1-855-769-7284) between 9:00 a.m. and 8:00 p.m. (Eastern), Monday through Friday.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Vosevi. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Contraindications

  • Vosevi is contraindicated with rifampin.

Warnings and Precautions

  • Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Vosevi due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
  • Risk of Reduced Therapeutic Effect Due to Concomitant Use of Vosevi with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: St. John’s wort and carbamazepine are not recommended for use with Vosevi as they may significantly decrease sofosbuvir, velpatasvir, and/or voxilaprevir plasma concentrations.

Adverse Reactions

  • The most common adverse reactions (≥10%, all grades) with Vosevi were headache, fatigue, diarrhea, and nausea.

Drug Interactions

  • Coadministration of Vosevi is not recommended with phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, atazanavir, lopinavir, tipranavir/ritonavir, efavirenz, rosuvastatin, pitavastatin, and cyclosporine due to changes (decreased or increased) in concentrations of sofosbuvir, velpatasvir, voxilaprevir, and/or the other agent.

Consult the full Prescribing Information for Vosevi for more information on potentially significant drug interactions, including clinical comments.

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 30 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 Vosevi for the treatment of adults with chronic HCV infection. 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, 2017, 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 Vosevi, including BOXED WARNING, is available at  www.gilead.com .

Vosevi is a trademark 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

Gilead Sciences, Inc.
Investors
Sung Lee, 650-524-7792
or
Media
Mark Snyder, 650-522-6167

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

Ant Financial to Share Full Suite of AI Capabilities with Asset Management Companies20.6.2018 01:10Pressemelding

Ant Financial Services Group (“Ant Financial” or “the Company”) today announced that the Company will share a full suite of AI capabilities with asset management companies in China to support their digital transformation. Following its successful launch last year, Caifuhao, an AI-powered corporate account on the Ant Fortune platform, has brought tangible benefits to 27 fund management companies. “By combining Ant Financial’s AI technologies with the capabilities of asset management companies in investor education and fund management, together we are making customized wealth management services more accessible for ordinary users,” said Eric Jing, Executive Chairman and CEO of Ant Financial. With the support of AI-powered services offered by their Caifuhao account, including operational optimization, content generation, compliance and risk management, 27 fund management companies have been able to increase their operational efficiency by 70% while reducing their overall costs by 50%. Add

Avalara Announces Closing of Initial Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares19.6.2018 21:20Pressemelding

Avalara, Inc. (NYSE: AVLR) today announced the closing of its initial public offering of 8,625,000 shares of common stock, including the full exercise by the underwriters of their option to purchase 1,125,000 additional shares of common stock, at a price to the public of $24.00 per share. The shares began trading on the New York Stock Exchange on June 15, 2018 under the symbol “AVLR.” Goldman Sachs & Co. LLC, J.P. Morgan, and BofA Merrill Lynch acted as book-running managers for the offering. JMP Securities, KeyBanc Capital Markets, and Stifel acted as co-managers. The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at 866-471-2526, or by email at prospectus-ny@ny.email.gs.com, or from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at

Unilever Calls on Content Creators and Distributors to Eradicate Stereotypes19.6.2018 17:42Pressemelding

Unilever is calling on content creators and distributors to act now to eliminate outdated stereotypes. The move marks the latest step in the company’s industry-leading Unstereotype initiative, which launched two years ago with the aim of eliminating harmful and diminishing portrayals of people across advertising. As part of its Unstereotype commitment Unilever is expanding that initiative across all forms of content and branded entertainment, and today announces a three-year multi-million-dollar deal with Rexona, the world’s biggest deodorant brand, and Simon Fuller’s XIX Entertainment. Rexona (also known as Sure, Degree and Shield depending on the country) will partner with NOW UNITED, the first ever global pop group comprised of 14 artists from 14 countries including Brazil, China, Germany, India, Philippines, Senegal, US and UK. Together, will co-create content across multiple channels that unites different cultures through the joy of dance, celebrating movement and inspiring people

Universal Laser Systems Expands Its Materials Database with Henkel, Hexcel and Saint-Gobain Materials19.6.2018 12:05Pressemelding

Universal Laser Systems (ULS) announces the addition of Henkel, Hexcel® and Saint-Gobain materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The Henkel, Hexcel and Saint-Gobain materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: Henkel Bergquist™ Gap Pad® VO Thermal Material Henkel Bergquist™ Hi-Flow® 105 Thermal Material Henkel LOCTITE® EA 7000 AERO Film Henkel Hysol® EA 9696 AERO Film Henkel Bergquist™ Sil-Pad A2000 Thermal Material Hexcel® HexForce® 353 Aramid Fabric Hexcel® HexForce® 282 Carbon Fabric Saint-Gobain CHEMFILM® DF100 Cast PTFE Film Saint-Gobain CHEMFILM® ETFE-E2 Extruded Fluoropolymer Film Laser processing notes, describing the results of the laser-material interaction fo

Valence Advises Itaúsa on Sale of Brazilian Chemical Co Elekeiroz to H.I.G. Capital19.6.2018 11:57Pressemelding

The Valence Group acted as advisor to Itaúsa on its sale of Brazilian chemical company Elekeiroz for R$160 million (EV), reduced by the net debt and proportionate to its shareholding (96.5% of total capital stock). The Company is a leading local producer of oxo-alcohols, plasticizers and anhydrides. About Itaúsa Itaúsa is a Brazilian holding company which controls several companies active in areas such as the financial sector; industries include wood panels, bathroom fittings and fixtures; infra-structure; and retail. It is one of the largest private conglomerates in Brazil and one of the largest in the world. About Elekeiroz Founded in 1894 and headquartered in Várzea Paulista – São Paulo, Elekeiroz operates in the chemicals manufacturing market. Through two production sites in Várzea Paulista and Camaçari – Bahia, the Company’s portfolio includes Oxo-Alcohols, Plasticizers, Phthalic & Maleic Anhydrides, Sulfuric Acid and other by-products. Elekeiroz has a diversified client base, com

Dole Adds Industry Veteran Michael Solomon as President of Dole Fresh Vegetables19.6.2018 10:00Pressemelding

Dole Food Company, Inc. announced the appointment of Michael H. Solomon as the new President of Dole Fresh Vegetables effective June 18, 2018. As Dole Fresh Vegetables President, Solomon will have responsibility for all of the division's operations across North America. He will report directly to Dole Food Company President and Chief Executive Officer Johan Linden. With 30 years experience, including within the food and beverage industry, Solomon has a proven success record of taking high-performance brands to the next level, increasing performance and margins in sales, plant operations, and profit growth. Among other positions, Solomon has held roles of President of POM Wonderful and President and CEO of Ready Pac Foods, Inc., prior to joining Dole. “Michael has built an impressive track record of strategic, operational and commercial accomplishments,” said Johan Linden, President and Chief Executive Officer of Dole Food Company. “He has considerable experience and knowledge of the fr