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A marketing application for LDV/SOF is also under review in the European Union, and was validated by the European Medicines Agency (EMA) on March 27, 2014. The agency has accepted Gilead's request for accelerated assessment of LDV/SOF, a designation that is granted to new medicines of major public health interest. If accepted, accelerated assessment could shorten the EMA's review time of LDV/SOF by two months, although it does not guarantee a positive opinion from the Committee for Medicinal Products for Human Use or approval by the European Commission.
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Gilead Sciences Inc s Ledipasvir Sofosbuvir Fixed Dose Combo Hep C Tablet Wins FDA Priority Review
FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection
FOSTER CITY, Calif. Gilead Sciences, Inc. Food and Drug Administration (FDA) has granted priority review to the company's New Drug Application (NDA) for a once daily fixed dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead filed the NDA for LDV/SOF on February 10, 2014, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014.
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.
LDV/SOF is an investigational product and its safety and efficacy have not yet been established.
SOF as a single agent was approved by the FDA under the tradename Sovaldi on December Michael Kors Black Bag Silver Chain
States have the genotype 1 strain of the virus.
Sovaldi is a registered trademark of Gilead Sciences, Inc.
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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 FDA, EMA and other regulatory agencies may not approve LDV/SOF fixed dose combination in the currently anticipated timelines or at all, Michael Kors Jet Set White and that any marketing approvals, if granted, may have significant limitations on its use. Further, additional studies of LDV/SOF, including results from the 24 week arms of ION 1, may produce unfavorable results. As a result, Gilead may not be able to successfully commercialize LDV/SOF, and may make a strategic decision to discontinue its development if, for example, the market for the product fails to materialize as expected. These risks, uncertainties and other factors could cause actual Michael Kors Purses Grey
The FDA has also assigned LDV/SOF a Breakthrough Therapy designation. The FDA grants Breakthrough Therapy designation and priority review status to investigational medicines that may offer major advances in treatment over existing options. The data submitted in the NDA are from three Phase 3 studies, ION 1, ION 2 and ION 3, and support the use of LDV/SOF in adults with genotype 1 HCV infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Approximately 75 percent of people infected with HCV in the United Michael Kors Hamilton Traveler Messenger
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. 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.
6, 2013 and by the European Commission on January 17, 2014.
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