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Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C
-- If Approved, Fixed-Dose Combination Would be First Oral Treatment Regimen for Patients with Genotype 1 HCV Infection, Eliminating Need for Both Interferon and Ribavirin --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) 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. The data submitted in the NDA support the use of LDV/SOF in patients with genotype 1 hepatitis C virus (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 States have the genotype 1 strain of the virus.
“Today’s filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “Based on the data from the Phase 3 ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks and without the need for interferon injections or ribavirin.”
The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks. Trial participants included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis.
Gilead plans to file for regulatory approval of LDV/SOF in other geographies, including the European Union, in the first quarter of 2014. Gilead has submitted an application to the European Medicines Agency (EMA) for accelerated assessment of LDV/SOF, a designation that is granted to new therapies and 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.
LDV/SOF is an investigational product and its safety and efficacy has not yet been established.
SOF as a single agent was approved by the FDA under the tradename Sovaldi® on December 6, 2013 and by the European Commission on January 17, 2014.
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 FDA may not approve the LDV/SOF fixed-dose combination, and that any marketing approvals, if granted, may have significant limitations on its use. In addition, Gilead may be unable to file for regulatory approval of LDV/SOF in other geographies in the currently anticipated timelines. Further, additional clinical 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 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, 2013, 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.
U.S. full prescribing information for Sovaldi is available at www.Gilead.com.
Sovaldi is a registered trademark of Gilead Sciences, Inc.
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 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)
- See more at: http://www.gilead.com/news/press-releases/2014/2/gilead-files-for-us-approval-of-ledipasvirsofosbuvir-fixeddose-combination-tablet-for-genotype-1-hepatitis-c#sthash.Fkb9VAVb.dpuf
Financial Releases
Corporate Releases
Product Releases
Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C
-- If Approved, Fixed-Dose Combination Would be First Oral Treatment Regimen for Patients with Genotype 1 HCV Infection, Eliminating Need for Both Interferon and Ribavirin --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) 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. The data submitted in the NDA support the use of LDV/SOF in patients with genotype 1 hepatitis C virus (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 States have the genotype 1 strain of the virus.
“Today’s filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “Based on the data from the Phase 3 ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks and without the need for interferon injections or ribavirin.”
The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks. Trial participants included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis.
Gilead plans to file for regulatory approval of LDV/SOF in other geographies, including the European Union, in the first quarter of 2014. Gilead has submitted an application to the European Medicines Agency (EMA) for accelerated assessment of LDV/SOF, a designation that is granted to new therapies and 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.
LDV/SOF is an investigational product and its safety and efficacy has not yet been established.
SOF as a single agent was approved by the FDA under the tradename Sovaldi® on December 6, 2013 and by the European Commission on January 17, 2014.
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 FDA may not approve the LDV/SOF fixed-dose combination, and that any marketing approvals, if granted, may have significant limitations on its use. In addition, Gilead may be unable to file for regulatory approval of LDV/SOF in other geographies in the currently anticipated timelines. Further, additional clinical 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 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, 2013, 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.
U.S. full prescribing information for Sovaldi is available at www.Gilead.com.
Sovaldi is a registered trademark of Gilead Sciences, Inc.
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 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)
- See more at: http://www.gilead.com/news/press-releases/2014/2/gilead-files-for-us-approval-of-ledipasvirsofosbuvir-fixeddose-combination-tablet-for-genotype-1-hepatitis-c#sthash.Fkb9VAVb.dpuf
Hi Rubye
I was dx hep c in 1990 and probably have has since 1977. I have GT 1a null responder (treated 3 times) with cirrhosis (dx 2005)
My Dr is going to try to get me onto Sovaldi and Olysio no interferon no Ribavirin and not wait for the Solvaldi Ledipasvir combo. I am presently compensated but who knows how long I will stay this way.
Based on the Cosmos study the American Assn for the Study of Liver Disease has issued practice guidelines (search AASLD.org practice guidelines) . For patients like me that is what they are recommending as 1st choice of therapy for null responders w/ cirrhosis.
Check in with your liver specialist and see if you can get that therapy authorized by your insurance if you have F3-F4 cirrhosis
Good luck to us all
Lynn
I was dx hep c in 1990 and probably have has since 1977. I have GT 1a null responder (treated 3 times) with cirrhosis (dx 2005)
My Dr is going to try to get me onto Sovaldi and Olysio no interferon no Ribavirin and not wait for the Solvaldi Ledipasvir combo. I am presently compensated but who knows how long I will stay this way.
Based on the Cosmos study the American Assn for the Study of Liver Disease has issued practice guidelines (search AASLD.org practice guidelines) . For patients like me that is what they are recommending as 1st choice of therapy for null responders w/ cirrhosis.
Check in with your liver specialist and see if you can get that therapy authorized by your insurance if you have F3-F4 cirrhosis
Good luck to us all
Lynn
If I were you I would wait just this wee bit of time. Wee bit in the scheme of things!
What's your geno tyoe? Have you been evaluated recently for your exact staging of cirrhosis, what does your hep doc say about waiting for better meds?
Gilead will be in the forefront for getting their meds approved first for geno tyoe 1's so that the newer protocol will do away with the current inf and RIBA. Others are trailing behind Gilead and have great combo meds too. Of course some docs are writing scripts for off label tx now too without inf., especially for those who are cirrhotic, have you looked into that possibility?
Gilead will be in the forefront for getting their meds approved first for geno tyoe 1's so that the newer protocol will do away with the current inf and RIBA. Others are trailing behind Gilead and have great combo meds too. Of course some docs are writing scripts for off label tx now too without inf., especially for those who are cirrhotic, have you looked into that possibility?
This news makes me want to wait. Wait some more I should say. I've never done tx and have had HCV since before they knew it was HCV. I've been having a problem getting on Sovaldi since I don't want the Interferon but with this newer tx in mind I may just wait some more. What the heck. What's one more year right. I like that you can take it with cirrhosis. Thanks for sharing this news.
Rubye
Rubye
Yes I do remember your posts from the ole days of tx. Sorry you didn't succeed either.
I'm another warrior that has been waiting and waiting since 2007 to re tx, definitely know that feeling, uuuugh. Your time is almost here and you'll finally get to tx with meds that don't make you sick anymore. The DAA's are amazing, I keep forgetting I'm on tx, cause I feel so good and it's as if I may even feel better now than before I began tx 2 wks ago! I'm glad I have alarms set on my phone to remind me I'm tx'ing and yes Mag take that next pill:)) I look forward to taking each pill, this is so exciting!
Take care,
Mag
I'm another warrior that has been waiting and waiting since 2007 to re tx, definitely know that feeling, uuuugh. Your time is almost here and you'll finally get to tx with meds that don't make you sick anymore. The DAA's are amazing, I keep forgetting I'm on tx, cause I feel so good and it's as if I may even feel better now than before I began tx 2 wks ago! I'm glad I have alarms set on my phone to remind me I'm tx'ing and yes Mag take that next pill:)) I look forward to taking each pill, this is so exciting!
Take care,
Mag
I am so happy to read this post.
I have had 2 viral breakthroughs previously and have been waiting, waiting, waiting, seems like forever. I think that I can now put a date to my next tx, anyway that it will be some time in the year 2015. That makes all the difference in the world to my outlook.
dointime
I have had 2 viral breakthroughs previously and have been waiting, waiting, waiting, seems like forever. I think that I can now put a date to my next tx, anyway that it will be some time in the year 2015. That makes all the difference in the world to my outlook.
dointime
Definitely want to take full advantage, there's no better time to tx then starting now or in upcoming Phase 3 trials or just wait for the best possible combos to get approved for the hardest to tx Geno 1 a's, especially in the tx experienced peeps. Best combos are almost here, getting ready for their FDA approvals.
I'm glad to see you opted out of starting tx with inf in the mix like your doc had first suggested, there's no need for you to do inf again, the DAA's alone will work even better with higher SVR's, as we've seen in phase 2 trials. ;)
As far as eradicating, it probably won't ever happen since HCV is pandemic and not everyone will have access to these meds, or not even know they are infected, sad but true.
I'm glad to see you opted out of starting tx with inf in the mix like your doc had first suggested, there's no need for you to do inf again, the DAA's alone will work even better with higher SVR's, as we've seen in phase 2 trials. ;)
As far as eradicating, it probably won't ever happen since HCV is pandemic and not everyone will have access to these meds, or not even know they are infected, sad but true.
Thank you and I'm definately hoping myself and all of us that need this are in a position by then to take full advantage. This could be the one that starts the eradication of this wicked disease.
It's nice seeing this post, so many gt 1's waiting for this combo, I think it will be a good one!
48weeks, I thought about you when I first saw this post. I know the waiting is not easy but this will all be worth the waiting, so just hang in there, your turn will come! Insurance is a concern but I think it will still be doable, keeping fingers crossed for all of you that are waiting for better meds, yopeeee!
Mag:)
48weeks, I thought about you when I first saw this post. I know the waiting is not easy but this will all be worth the waiting, so just hang in there, your turn will come! Insurance is a concern but I think it will still be doable, keeping fingers crossed for all of you that are waiting for better meds, yopeeee!
Mag:)
Great news! We should see LDV/SOF available on the market in about 9-10 months just like we did with the current Sovaldi treatments with ribavirin and ribavirin and peg-interferon. Gilead filed the NDA for the currently approved treatment on April 8, 2013 and it was approved December 6th (9 months) and then it took about a month for insurance approval.
Great news for all of us with hepatitis C! No more peg-interferon and ribavirin!
Hector
Great news for all of us with hepatitis C! No more peg-interferon and ribavirin!
Hector
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