Business Wire

CA-GILEAD-SCIENCES,-INC.

Share
European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes

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 Marketing Authorization Application (MAA) for Vosevi® , an investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients. The data included in the application support the use of SOF/VEL/VOX in patients with and without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy, including 8 weeks of treatment for HCV direct-acting antiviral (DAA)-naïve patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen.

The CHMP positive opinion was adopted following an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest. The 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, Norway and Iceland.

The MAA for SOF/VEL/VOX is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4), evaluated 12 weeks of the single tablet regimen in patients with genotypes 1-6 HCV infection previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of SOF/VEL/VOX in DAA-naïve patients with genotypes 1-6 HCV infection. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with SOF/VEL/VOX (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with genotypes 1-6 HCV infection with and without cirrhosis treated with SOF/VEL/VOX (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and cirrhosis treated with SOF/VEL/VOX (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse events among patients who received SOF/VEL/VOX in the POLARIS studies were headache, fatigue, diarrhea and nausea.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi® , for use in combination with other agents. The single tablet regimen of sofosbuvir (400 mg) and ledipasvir (90 mg) received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni® . The single tablet regimen of sofosbuvir (400 mg) and velpatasvir (100 mg) received marketing authorization in the European Union on July 8, 2016, under the trade name Epclusa® .

Gilead has also submitted a regulatory application for SOF/VEL/VOX in the United States. Gilead filed the New Drug Application for SOF/VEL/VOX on December 8, 2016, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act of August 8, 2017.

SOF/VEL/VOX is an investigational product and its safety and efficacy has not been established and is not approved anywhere globally.

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 worldwide. Gilead has operations in more than 40 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 the European Commission or other regulatory agencies, including the FDA, may not approve SOF/VEL/VOX for the treatment of chronic hepatitis C and that any marketing approvals, if granted, may have significant limitations on its use. As a result, Gilead may not be able to successfully commercialize SOF/VEL/VOX for chronic hepatitis C. 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 10Q 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.

Full European Summary of Product Characteristics for Sovaldi, Harvoni and Epclusa are available from the EMA website at www.ema.europa.eu .

Vosevi, Sovaldi, Harvoni and Epclusa 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 or call Gilead Public Affairs at 1-650-574-3000.

Contact:

Gilead Sciences, Inc.
Investors
Sung Lee, +1 650-524-7792
or
Media (U.S.)
Mark Snyder, +1 650-522-6167
or
Media (Europe)
Arran Attridge, +44 (208) 587-2477

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

NIKE, Inc. Board of Directors Announces Long-Time Nike Veteran Elliott Hill to Return as President and Chief Executive Officer John Donahoe to Retire from Nike19.9.2024 22:15:00 CEST | Press release

The Board of Directors of NIKE, Inc. (NYSE:NKE) announced today that Elliott Hill will become President and Chief Executive Officer of NIKE, Inc., effective October 14, 2024. Hill will also become a Director of the NIKE, Inc. Board of Directors and a member of the Executive Committee. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919388699/en/ Incoming NIKE, Inc. President & CEO Elliott Hill (Photo: Business Wire) “I am excited to welcome Elliott back to NIKE. Given our needs for the future, the past performance of the business, and after conducting a thoughtful succession process, the Board concluded it was clear Elliott’s global expertise, leadership style, and deep understanding of our industry and partners, paired with his passion for sport, our brands, products, consumers, athletes, and employees, make him the right person to lead Nike’s next stage of growth,” said Mark Parker, Executive Chairman of NIKE, Inc. “Pers

Andersen Global styrker båndene i Asien med yderligere medlemsvirksomheder19.9.2024 20:53:00 CEST | Pressemeddelelse

Andersen Global tilføjer medlemsvirksomheder i Asien og Stillehavsområdet, hvor VDB Loi-kontorerne i Cambodja og Vietnam tager Andersen-brandet i brug. Andersen i Cambodja og Andersen i Vietnam har under ledelse af Managing Partner Jean Loi og Senior Partner Edwin Vanderbruggen arbejdet i regionen i mere end 10 år. De udbyder en omfattende suite af skatterelaterede og juridiske tjenester, herunder inden for bankvæsen og finans, fusioner og opkøb, virksomhedsrådgivning, skatterådgivning, transfer pricing og tvister og retssager. "Efterhånden som det økonomiske landskab udvikler sig og bliver mere komplekst, går vores kunders forventninger og behov samme vej," siger Edwin. "Ved at blive medlemsvirksomhed i Andersen Global styrker vi vores evne til at levere branchens bedste integrerede service i hele Cambodja og Vietnam. Ved at tage brandet i brug kan vi også accelerere vores vækst, hvilket sætter os i stand til at navigere i et meget indviklet marked med uovertruffen ekspertise." "Med s

Mary Kay Expands Into Kyrgyzstan, Further Elevating Beauty and Empowerment Around the World19.9.2024 19:03:00 CEST | Press release

Mary Kay Inc., a global leader in skin care and cosmetics, is proud to announce its expansion into Kyrgyzstan, marking a significant milestone in its ongoing international growth strategy. This exciting development underscores Mary Kay’s commitment to empowering women and providing innovative, high-quality skincare and beauty products across the globe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919159057/en/ Mary Kay’s expansion into Kyrgyzstan marks another step forward in the company’s mission to enrich women’s lives around the world, offering top-tier beauty products and unparalleled business opportunities. (Photo: Mary Kay Inc.) The beauty and personal care market is experiencing robust growth internationally, with sales volume in these categories almost doubling over the past several years. The beauty market is expected to reach approximately $580 billion by 2027, growing by a projected 6 percent per year1 while

Xsolla Partners With AbleGamers for Charity Campaign at TwitchCon 202419.9.2024 19:00:00 CEST | Press release

Collect Limited Edition Pins at TwitchCon and Help Us Raise Up To $10,000 for AbleGamers Xsolla, a global video game commerce company, is excited to announce its collaboration with AbleGamers for an impactful charity campaign at TwitchCon 2024. This partnership aims to further AbleGamers' mission of improving accessibility in gaming for individuals with disabilities through an interactive and meaningful activation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919722398/en/ (Graphic: Xsolla) Attendees who visit the Xsolla booth (Booth 1515-SW) at TwitchCon will have the exclusive opportunity to claim one of two specially designed charity pins. By sharing a photo of their pin on their social channels on Instagram, Facebook, or Twitter using the hashtags #LightstreamAble and #XsollaAble, participants will help raise funds for AbleGamers. For every qualifying social post, Xsolla and its partners will donate $5 to AbleGamers

Sandvine Announces New Ownership and Capital Infusion19.9.2024 18:38:00 CEST | Press release

New ownership group commits new financingWill help to support reorientation of business and continued customer service and technological innovation Sandvine (the “Company”), a market-leading provider of Over-the-Top (OTT) Application Classification and Quality of Experience (QoE) solutions, today announced that it has been acquired by a group of leading US investment firms that previously were, and continue to be, lenders to the Company. In connection with this change of control transaction, the lenders agreed to reduce the Company’s total outstanding debt significantly. Following the change of control transaction, on September 13, 2024, these investors also entered into a binding agreement to provide new capital to Sandvine. The financing is expected to close in September 2024 and will strengthen the Company’s balance sheet. These enhancements to Sandvine’s financial position accompany its recently announced reorientation of its business model to focus on serving customers in large de

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
HiddenA line styled icon from Orion Icon Library.Eye