Food and drug administration approves gileads sovaldi. It is only recommended with some combination of ribavirin, peginterferonalfa, simeprevir, ledipasvir, daclatasvir, or velpatasvir. Sovaldi sofosbuvir dose, indications, adverse effects. Hepatitis c sovaldi sofosbuvir is a hepatitis c virus hcv nucleotide analog ns5b polymerase inhibitor indicated for the treatment of adult patients with genotype 1, 2, 3 or 4 chronic. Hepatitis c epclusa sofosbuvir and velpatasvir is a nucleotide analog polymerase inhibitor and pangenotypic ns5a inhibitor fixeddose combination for the treatment of chronic genotype 16. Fda for olysio simeprevir for oncedaily use in combination with sofosbuvir for 12. Patents and exclusivity apply to drugs in different ways. Highlights of prescribing information these highlights do not.
New drug application submitted for sofosbuvirvelpatasvir. Sofosbuvir, a ns5b polymerase inhibitor in the treatment. The clinically approved antiviral drug sofosbuvir inhibits. Sofosbuvir has a number of ideal properties, including once daily dosing, no meal restrictions, few adverse effects, minimal drugdrug interactions, high genetic barrier to resistance, and relatively good safety and efficacy in patients with advanced liver disease. Randomized clinical trial of sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks in noncirrhotic subjects infected with chronic hepatitis c virus genotype 1 tnt the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Fda and are still used exclusively by the agency to evaluate 100% of the electronic submissions it receives. Sovaldi is a drug marketed by gilead sciences inc and is included in two ndas. The standard solutions of sofosbuvir were run using the optimized condition to evaluate the prediction accuracy. Olysiosovaldi combo becomes 2nd fdaapproved alloral hcv. Janssen submits supplemental new drug application to u. Discuss the evidence for sofosbuvir in hepatitis c genotype 1 patients. Practical data obtained for both the trials approximately matches with the data provided by software which shows the authenticity of the software. Gileads sofosbuvir gains fda approval, attracts patent. The us food and drug administration fda has approved the firstinkind nucleotide analog inhibitor sofosbuvir sovaldi, gilead sciences, inc for the treatment of adults with chronic hepatitis c.
Cure rates are 30 to 97% depending on the type of hepatitis c virus involved. Food and drug administration fda in december 20 for the treatment of chronic hepatitis c virus hcv infection in combination with ribavirin or peginterferon and ribavirin. Mercks zepatier was fda approved early in 2016 and is now available. The current studies details qbd enable development of a simple, rapid, sensitive and costeffective highperformance liquid chromatographic method for estimation of sofosbuvir. Sofosbuvir uses, dmf, dossier, manufacturer, supplier. The fda states in its press release that harvoni is the third drug for hcv approved in the past year, including sovaldi and janssens olysio simeprevir. Treatment of hepatitis c virus infection with generic.
Sofosbuvir, sold under the brand name sovaldi among others, is a medication used to treat hepatitis c. Our ectd submission software has been built to fulfill regulatory needs holistically and end to end. Sofosbuvir is nucleotide analog inhibitor, which specifically inhibits hcv ns5b polymerase. Sofosbuvir is used with other antiviral medications such as ribavirin, peginterferon, daclatasvir to treat chronic longlasting hepatitis c, a viral infection of the liver. To prepare a dose of ledipasvir and sofosbuvir pellets with food, sprinkle the entire packet of pellets on one or more spoonfuls of cold or room temperature nonacidic soft food such as pudding, chocolate syrup, mashed potato, or ice cream. Guidance for the design of bioequivalence studies taking into account the pharmacokinetic properties of sofosbuvir, the following guidance with regard to the study design should be taken into account. Guidance for the content of premarket submissions for software contained in medical devices. The fda s esubmitter software is part of an electronic submissions process that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types.
Shortened 12 week course of therapy for many patients. The responses obtained after carrying out trail runs were entered back to doe software and the. Sofosbuvir is a medication used as part of combination therapy to treat hepatitis c virus hcv infection or hcv and hiv coinfection. Ledipasvirsofosbuvir was approved by the us food and drug administration fda on october 10, 2014. Gileads sofosbuvir gains fda approval, attracts patent battle. The partition coefficient log p for sofosbuvir is 1.
All data were analyzed with graphpad prism software. The fixeddose combination of ledipasvir sofosbuvir provides an effective and welltolerated onepill onceaday option for treatment of genotypes 1, 4, 5, and 6 chronic hepatitis c hcv infection. Save the installation zip file to your computer and extract the jinstall. Risk of hepatitis b virus reactivation in patients coinfected with hcv and hbv see full prescribing information for complete boxed warning.
Guidance for the content of premarket submissions for. Assay and dissolution methods development and validation. Fda for olysio simeprevir for oncedaily use in combination with sofosbuvir for 12 weeks for the treatment of adult patients with. Gileads sofosbuvir is fda approved fda news release for immediate release. Stabilityindicating method and lcmsms characterization. Content of premarket submissions for software contained in. Sofosbuvir is a novel direct acting antiviral agent against hepatitis c virus. We evaluated whether sofosbuvir, an fdaapproved nucleotide polymerase inhibitor. Sofosbuvir is the first compound in the ns5b polymerase inhibitor class to reach this stage of development in the us, and looks set to become a major new treatment for hepatitis c if the fda follows its committees advice and approves the drug. Fda approves first combination pill to treat hepatitis c hhs. Our vision is to keep it as simple as possible while delivering compliance and fulfilling fda 21cfr11, eu annex 11, ich, and gxp requirements. Not known whether sofosbuvir or metabolites are present in human breast milk, affect human milk production or have effects on breastfed infant. Sovaldi 400 mg film coated tablets summary of product.
Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Development of sofosbuvir for the treatment of hepatitis c. Sovaldi sofosbuvir is an expensive drug used to treat hepatitis c. The creator of the hepatitis c treatment sofvelvox, gilead, has submitted a new drug application nda to the u. May 09, 2020 sovaldi is a drug marketed by gilead sciences inc and is included in two ndas. Ledipasvir and sofosbuvir pellets can be swallowed without chewing or they can be taken with food. Hepatitis c epclusa sofosbuvir and velpatasvir is a nucleotide analog polymerase inhibitor and pangenotypic ns5a inhibitor fixeddose combination for the. Epclusa sofosbuvir and velpatasvir is a nucleotide analog polymerase inhibitor and pangenotypic ns5a inhibitor fixeddose combination for the treatment of chronic genotype 16 hepatitis c virus hcv infection. This drug has three hundred and thirtyseven patent family members in fortyseven countries. Sovaldi sofosbuvir dosing, indications, interactions. Fda approves game changer hepatitis c drug sofosbuvir. Aidsinfo provides the following drug label solely as an example of the labels available for ledipasvirsofosbuvir. Fda for alloral, oncedaily olysio simeprevir in combination with sofosbuvir filing supported by data from the phase 3 optimist1 and. If a patient has a serious adverse reaction potentially related to peginterferon alfa andor ribavirin, the peginterferon alfa andor ribavirin dose should be reduced or discontinued.
Todays approval represents a significant shift in the treatment. Sofosbuvir is a pangenotypic inhibitor of the hcv ns5b rnadependent rna polymerase, which is essential for viral replication 4. Treatment of hepatitis c virus infection with generic sofosbuvirledipasvir in iranian patients hepcc2 the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Epclusa is a fixeddose combination of sofosbuvir, a hepatitis c virus hcv nucleotide analog ns5b polymerase inhibitor, and velpatasvir, an hcv ns5a inhibitor, and is indicated for the treatment. Nov 14, 2015 in a prepostnatal development study with ledipasvir or sofosbuvir, plasma exposure in neonate rats was approximately 4fold lower than the maternal plasma for ledipasvir postparturition day 10, and the ratio of neonatal to maternal plasma exposure was less than 0. Sovaldis approval is supported primarily by data from four phase 3. On november 12, 2015 the fda expanded the approval of ledipasvirsofosbuvir to include a treatment of chronic hepatitis c genotypes 4, 5, and 6 and b patients coinfected with hiv.
Food and drug administration fda for the hep c treatment. The federal agency based its approval on three clinical trials with 1,518 patients. When administered to lactating rats, ledipasvir was detected in the plasma of suckling rats likely due to the presence of ledipasvir in milk, without clear effects on nursing pups. Sovaldi is the second drug approved by the fda in the past two weeks to treat. New hepatitis c drug approved by fda, sovaldi sofosbuvir. The major metabolite, gs331007, is not a substrate of either pgp or bcrp. This directacting antiviral regimen was the first fda approved interferon and ribavirin free regimen to treat hepatitis c.
Hepatitis c gileads sovaldi sofosbuvir is now fda approved. Harvoni, a oncedaily fixeddose combination of the directacting antiviral agents ledipasvir and sofosbuvir approved by the fda in 2014 for treatment of hepatitis c virus hcv genotype 1 infection,1 has now been approved for use in patients infected with hcv genotype 4, 5, or 6, and in patients coinfected with hcv and hiv1. In vitro, the active triphosphate inhibits recombinant ns5b polymerases from hcv genotypes 14 with. Epclusa sofosbuvir and velpatasvir fda approval history. Olysio has been approved by the fda, in combination with sovaldi, for the. It is available as a fixeddose combination tablet containing ledipasvir 90 mgsofosbuvir 400 mg. The fda has approved daclatasvir daklinza bms, an oral directacting antiviral drug, for use with sofosbuvir sovaldi for treatment of chronic hepatitis c virus hcv genotype 3 infection.
Quality by design qbd refers to the achievement of certain predictable quality with a predetermined and desired specification. Several fdaapproved drug labels may be available for sofosbuvir. Sep 06, 2019 our sovaldi sofosbuvir side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Sovaldi sofosbuvir tablets, for oral use sovaldi sofosbuvir oral pellets initial u. To download the fda esubmitter software, click on the following link. Cunesoft offers a ready to use, prevalidated and highly secure cloud based regulatory compliance suite.
Sofosbuvir was a breakthrough new medication for the treatment of patients with chronic hepatitis c. On october 10, 2014, the fixeddose combination ledipasvirsofosbuvir harvoni was approved by the fda for the treatment of chronic hepatitis c genotype 1 infection in adults. Sofvelvox has been submitted as an oncedaily single pill regimen for the treatment of directacting antiviral daaexperienced chronic hepatitis c virus hcv. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Gilead submitted the new drug application for sofosbuvir in combination with ribavirin in april 20, and in october 20 it received the fdas breakthrough. Sovaldi sofosbuvir is a hepatitis c virus hcv nucleotide analog ns5b polymerase inhibitor indicated for the treatment of. Hepatitis b virus hbv reactivation has been reported, in some. You may report side effects to fda at 1800 fda 1088.
Inclusion or absence of a drug label on the aids info site does not imply endorsement or lack thereof by aids info. Aids info provides the following drug label solely as an example of the labels available for ledipasvirsofosbuvir. There are nine patents protecting this drug and one paragraph iv challenge. In the present work, a rapid, specific and reproducible isocratic reversed phase high performance liquid chromatography rphplc method has been developed and validated for the determination of sofosbuvir in the presence of its stressed degradation products. The pharmacokinetics of sofosbuvir, and gs331007 were studied in hcvinfected patients with esrd requiring dialysis treated with ledipasvir sofosbuvir n 94 for 8, 12, or 24 weeks or sofosbuvir velpatasvir n 59 for 12 weeks, and compared to patients without renal impairment in the ledipasvir sofosbuvir and sofosbuvir velpatasvir phase 2. Randomized clinical trial of sofosbuvir in combination. Guidance for the content of premarket submissions for software contained in medical devices guidance for industry and fda staff may 2005. Frequently asked questions on patents and exclusivity fda. Our sovaldi sofosbuvir side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Food and drug administration fda this week announced additional approval of interferonfree oral therapy for chronic hepatitis c combining janssens hcv protease inhibitor simeprevir olysio plus gilead sciences hcv polymerase inhibitor sofosbuvir sovaldi, both of which were approved separately in late 20. Inducers and inhibitors of these transporters may alter the plasma concentration of sofosbuvir. Ledipasvirsofosbuvir harvoni treatment hepatitis c online. This paper describes the development of sofosbuvir up to its original fda approval.
Sofosbuvir is a prodrug of 2deoxy2fluoro2cmethyluridine monophosphate that is converted within hepatocytes to its active uridine triphosphate form, causing chain termination during replication of the viral genome murakami et al. Jan 18, 2017 zika virus zikv is a member of the flaviviridae family, along with other agents of clinical significance such as dengue denv and hepatitis c hcv viruses. The fdaapproved drug sofosbuvir inhibits zika virus infection. Drugs that induce pgp may reduce the therapeutic effect of sofosbuvir. Sofosbuvir is a previously approved hcv drug marketed under the.
Pharmacy and fda information viral hepatitis and liver. Gileads sofosbuvir aces fda advisory committee pmlive. Aidsinfo provides the following drug label solely as an example of the labels available for sofosbuvir. Ab the nucleotide analog ns5b polymerase inhibitor sofosbuvir was approved by the u. The pharmacokinetics of sofosbuvir, and gs331007 were studied in hcvinfected patients with esrd requiring dialysis treated with ledipasvirsofosbuvir n 94 for 8, 12, or 24 weeks or sofosbuvirvelpatasvir n 59 for 12 weeks, and compared to patients without renal impairment in the ledipasvirsofosbuvir and sofosbuvirvelpatasvir phase 2. Below is an edited excerpt from a gilead press release describing the fda submission. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Several fdaapproved drug labels may be available for ledipasvirsofosbuvir. Sofosbuvir was approved by the fda in december 20, and is marketed under the brand name sovaldi. Sofosbuvir, a ns5b polymerase inhibitor in the treatment of. Selected resources for health care providers on treatment of hepatitis c, from the va national viral hepatitis and liver disease website.
Sovaldi sofosbuvir approved for use in genotypes 1, 2, 3, or 4 high cure rates with an overall response rate of 90% in most gentotypes. Apply for and manage the va benefits and services youve earned as a veteran, servicemember, or family memberlike health care, disability, education, and more. Hepatitis c sovaldi sofosbuvir is a hepatitis c virus hcv nucleotide analog ns5b polymerase inhibitor indicated for the treatment of adult patients with. Dec 08, 2015 randomized clinical trial of sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks in noncirrhotic subjects infected with chronic hepatitis c virus genotype 1 tnt the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The product should be stored at room temperature below 30c 86f. It is not covered by most medicare and insurance plans, but manufacturer and pharmacy coupons can help offset the cost. Side effects of sovaldi sofosbuvir tablets, warnings, uses. In the initial phase ii studies, sofosbuvir was evaluated in combination with peginterferon and ribavirin pegrbv. Randomized clinical trial of sofosbuvir in combination with. Aids info provides the following drug label solely as an example of the labels available for sofosbuvir.
Dec 08, 2016 the creator of the hepatitis c treatment sofvelvox, gilead, has submitted a new drug application nda to the u. In a 28day, doseranging trial in subjects infected with genotype 1 hcv, 64 patients were randomized to receive one of three oncedaily doses of oral sofosbuvir 100, 200 or 400 mg or placebo plus peginterferon and ribavirin for 28 days, after which all. Fda approves gileads harvoni sovaldiledipasvir combination. Daclatasvir is the first drug approved for this indication that does not require the addition of interferon or ribavirin. It is usually taken with or without food once a day. Call your doctor for medical advice about side effects. Approval of ledipasvirsofosbuvir fixeddose combination tablet for genotype 1 hepatitis c if approved, fixeddose combination would be first oral treatment regimen for patients with genotype 1 hcv infection, eliminating need for both. New hepatitis c drug approved by fda, sovaldi sofosbuvir by. Meet the best ectd submission software solution available. The predominant circulating metabolite of sofosbuvir gs331007 was the primary component observed in the milk of lactating rats, without effect on nursing pups. Zika virus zikv is a member of the flaviviridae family, along with other agents of clinical significance such as dengue denv and hepatitis. If a patient has a serious adverse reaction potentially related to peginterferon alfa andor ribavirin, the peginterferon alfa andor ribavirin dose should be. Mar 18, 2015 ledipasvirsofosbuvir was approved by the us food and drug administration fda on october 10, 2014. Patents can be issued or expire at any time regardless of the drugs approval status.