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European Commission Grants Marketing Authorization for Gilead's Harvoni® (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4
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- Once-Daily Single Tablet Regimen Eliminates the Need for Interferon and Ribavirin for Patients with Genotype 1 and 4 Hepatitis C without Cirrhosis or with Compensated Cirrhosis -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 18, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir (LDV) with the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved by the European Commission under the tradename Sovaldi® inJanuary 2014.
Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and is recommended in treatment-naïve and treatment-experienced cirrhotic and non-cirrhotic genotype 1 and 4 patients with a treatment duration of 12 or 24 weeks depending on prior treatment history and cirrhosis status. Eight weeks of treatment with Harvoni may be considered in non-cirrhotic treatment-naïve genotype 1 patients. In genotype 1 and 4 patients with decompensated cirrhosis, and genotype 3 patients with cirrhosis and/or prior treatment failure, Harvoni should be used in combination with ribavirin for 24 weeks. Harvoni is also indicated for patients with HCV who have HIV co-infection.
Today's marketing authorization is based on the clinical development program that included more than 2,000 patients with HCV infection, and follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest. It allows for the marketing of Harvoni in all 28 countries of the European Union (EU).
"Genotype 1 patients living with hepatitis C in Europe and the physicians who treat them have been waiting for a treatment advance like this for decades," said Graham Foster, MD, Professor of Hepatology, Queen Mary University of London. "With Harvoni, we have the potential to transform the way we treat people living with the most prevalent form of hepatitis C in Europe. We can now expect very high SVR rates, and for many patients, we can eliminate the need for interferon injections and ribavirin and offer a cure in a once-daily tablet."
The marketing authorization is supported primarily by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease.
These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=1,080) achieved SVR12 rates of 94 to 99 percent.
The approval was also supported by preliminary data from the SOLAR-1 trial, which evaluated difficult to treat patients with decompensated cirrhosis and patients who have undergone liver transplantation, and from the ERADICATE trial, which evaluated genotype 1 HCV patients co-infected with HIV. The primary endpoint in these studies was SVR12. At the time of submission, only preliminary results were available. In the SOLAR-1 trial, participants with decompensated cirrhosis receiving a 12-week treatment regimen of Harvoni plus ribavirin had an SVR4 rate of 90 percent (n=45/50). In post-liver transplant patients without decompensated liver disease, SVR4 rates were greater than 95 percent (n=109). In an interim analysis of the ERADICATE trial, 40 of the 50 patients had reached 12 weeks post treatment and had SVR12 rates of 98 percent (n=39/40).
The ELECTRON-2 trial, a Phase 2 open-label study, provided preliminary data on genotype 3 infected HCV patients demonstrating 100 percent (n=26/26) SVR12 when Harvoni was used in combination with ribavirin for 12 weeks.
In these clinical studies, fatigue and headache were more common in patients treated with Harvoni compared to placebo.
Harvoni was approved by the U.S. Food and Drug Administration and Health Canada in October 2014 and in New Zealand in November 2014. Regulatory submissions for Harvoni are pending in Japan and Switzerland. Sovaldi as a single agent is approved for use in the European Union and in the United States, Canada, Australia, New Zealand, Egypt, Switzerland and Turkey.
Important Safety Information
The summary of product characteristics of co-prescribed medicinal products should be consulted before starting therapy with Harvoni.
Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir.
In clinical studies, fatigue and headache were more common in patients treated with Harvoni compared to placebo.
Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with rosuvastatin or St. John's wort (Hypericum perforatum) is contraindicated. Co-administration with certain P-glycoprotein (P-gp) inducers (e.g. rifampicin, carbamazepine and phenytoin) is not recommended. Monitoring of digoxin and dabigatran is recommended when used with Harvoni. Caution and frequent renal monitoring is recommended for co-administration with certain HIV antiretroviral regimens. Safety has not been established in patients with severe renal impairment. For patients on statins dose reduction should be considered and careful monitoring for statin adverse events (myopathy and rhabdomyolysis) should be undertaken. A Summary of Product Characteristics is available at www.ema.europa.eu.
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. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.
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 and patients may not see advantages of Harvoni over other therapies and may therefore be reluctant to prescribe the product, and the risk that private and public payers may be reluctant to provide coverage or reimbursement for the product. Further, additional studies of Harvoni may produce unfavorable results. 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 September 30, 2014, 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.
Harvoni and Sovaldi 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, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at +1 (650) 574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O'Brien, +1-650-522-1936 (Investors)
Cara Miller, +1-650-522-1616 (Media, U.S.)
Arran Attridge, +44 208 587 2477 (Media, Europe)
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