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EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATION FOR GILEAD’S EPCLUSA®▼ (SOFOSBUVIR/VELPATASVIR) FOR THE TREATMENT OF ALL GENOTYPES OF CHRONIC HEPATITIS C

Lehdistötiedote   •   Heinä 11, 2016 08:54 EEST

EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATION FOR GILEAD’S EPCLUSA® (SOFOSBUVIR/VELPATASVIR) FOR THE TREATMENT OF ALL GENOTYPES OF CHRONIC HEPATITIS C

– Epclusa is the First and Only All-Oral, Single Tablet Regimen for all Genotypes (1-6) of Chronic Hepatitis C Virus Infection and is Gilead’s Third Sofosbuvir-Based Treatment –

The European Commission has granted marketing authorization for Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

“This approval provides us with the first option to offer a simple and effective cure for the majority of HCV-infected patients, regardless of genotype,including genotype 3, the most aggressive HCV genotype which often is the least responsive to treatment with new DAAs,” said Professor Martti A. Färkkilä of Helsinki University Central Hospital, one of Finland’s leading experts in the field.

The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).SOF/VEL is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV.Physicians may also consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.

The Marketing Authorization follows an accelerated review procedure by the European Medicines Agency, reserved for medicinal products expected to be of major public health interest. It allows for the marketing of SOF/VEL in all 28 countries of the European Union.

SOF/VEL is Gilead’s third sofosbuvir-based treatment to be granted Marketing Authorization by the European Commission for the treatment of chronic HCV infection. Sofosbuvir-based regimens are recommended by global guidelines across all HCV genotypes and disease severities.1,2 Today, nearly one million patients worldwide have been prescribed a sofosbuvir-based regimen.3

The authorization of SOF/VEL is supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4.4,5,6 In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of SOF/VEL.4,5 The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of SOF/VEL with or without RBV or 24 weeks of SOF/VEL alone.6 The primary endpoint for all studies was the sustained viral responserate 12 weeks after treatment (SVR12).4,5,6

“The burden of hepatitis C across Europe is substantial and growing rapidly with approximately 15 million people chronically infected,” Said John Milligan, Ph.D., President and Chief Executive Officer of Gilead.“The European approval of SOF/VEL reflects our continued focus to bring a cure to all infected patients across the region and we look forward to working with physicians, healthcare providers and governments to make it available as quickly as possible.”

Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12.4,5 In ASTRAL-4, patients with decompensated cirrhosis receiving SOF/VEL with RBV for 12 weeks achieved a higher SVR12 rate (94 percent) compared to those who received SOF/VEL for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively.)6 The most common adverse events in the four ASTRAL studies, were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.4,5,6

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the trade name Sovaldi®▼. The fixed-dose combination of sofosbuvir (400mg) and ledipasvir (90mg) received marketing authorization in the European Union on November 18, 2014 under the trade name Harvoni®▼.

Epclusa was approved by the U.S. Food and Drug Administration on June 28, 2016 for the treatment of adults with genotype 1-6 chronic HCV infection.

Important Safety Information
Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with potent P-glycoprotein (P-gp) or potent cytochrome P450 (CYP) inducers (e.g. rifampicin, rifabutin, St. John’s wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin) is contraindicated.

Caution and frequent renal monitoring is recommended for co-administration with certain HIV antiretroviral treatments (e.g. tenofovir disoproxil fumarate) and efavirenz-containing regimens are not recommended. Safety has not been established in patients with severe renal impairment (glomerular filtration rate <30ml/min).

Monitoring of digoxin, dabigatran and amiodarone is recommended when used with sofosbuvir/velpatasvir. For patients on statins dose reduction should be considered and careful monitoring for statin adverse events (myopathy and rhabdomyolysis) should be undertaken.

The “interaction with other medicinal products and other forms of interaction” section of the Epclusa EU Summary of Product Characteristics (SmPC) should be consulted before starting therapy with sofosbuvir/velpatasvir.

Sofosbuvir/velpatasvir should not be administered concomitantly with other medicinal products containing sofosbuvir.

In clinical studies, adverse events were comparable to placebo, with fatigue, headache and nausea the most commonly reported side effects.

Please refer to the SmPC for further details. The SmPC is available at www.ema.europa.eu.

CONTACT: Göran Skoglund, Medical Director Gilead Nordic, +46 (0)7 08 73 44 64.

About Gilead
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 Epclusa. 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, 2016 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.

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

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 Nordic at telephone: +46 (0)8 505 718 00

▼Black triangle indicates that product is subject to additional monitoring.

1European Association for the Study of the Liver (EASL). Journal of Hepatology (2015);63:199–236. [Accessed June 2016]. Available from: http://www.easl.eu/medias/cpg/HEPC-2015/Full-report.pdf

2WHO guidelines for the screening, care and treatment of persons with chronic hepatitis C infection. [Accessed June 2016]. Available from: http://www.who.int/hepatitis/publications/hepatitis-c-guidelines-2016/en/

3John Milligan on behalf of Gilead Sciences Inc. at Gilead Annual Stockholders Meeting, May 5, 2016

4Feld JJ, et al. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection (ASTRAL-1). The New England Journal of Medicine 2015; 373(27):2599-2607

5Foster GR, et al. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection (ASTRAL-2-3). The New England Journal of Medicine 2015; 373(27):2608-2617

6Curry MP, et al. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis (ASTRAL-4). The New England Journal of Medicine 2015; 373(27):2618-2628

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific. The Nordic Organization started up 2008, and the head office is based in Stockholm, Sweden.

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