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Daklinza and hard to treat Hep C folk
I found this today in a Fierce PharmaMarketing article dated today, 10-7-15. To read the whol article, you can go to bmsnews.com:
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Can Daklinza profit from a set of niche hep C uses? BMS may soon find out
October 7, 2015 | By Carly Helfand
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Gilead ($GILD) and AbbVie ($ABBV) may be dominating the hep C field with their next-gen combo treatments, but that doesn't mean there's no room for other companies to sneak in.
Bristol-Myers Squibb ($BMY), for one, is preparing to do just that with Daklinza, a med that Tuesday nabbed the FDA's priority review tag for a trio of new indications in hard-to-treat patients. Regulators will examine the med for use with Gilead's Sovaldi in those who are coinfected with HIV-1, suffering from advanced cirrhosis, or experiencing recurrence of hep C after a liver transplant.
And Bristol has some experience in that department. In July, it won FDA approval for use alongside Sovaldi in patients with difficult-to-treat hep C genotype 3. It also snagged a breakthrough designation from the FDA in May for treating genotype 1 patients with advanced.......
Douglas Manion
"Hepatitis C is not a one-size-fits-all, monolithic disease," Douglas Manion, BMS' head of specialty development, said in a statement. "Our focus for the Daklinza-sofosbuvir regimen centers on addressing the needs of HCV patient subpopulations who need new options even in light of the extraordinary advances that have occurred in HCV treatment."
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Since I want to be sure and not violate copyright laws, I have included the author, date, article title, and publishing organ.
Great news not only for Gt3s but also for coinfected persons, and/or those with cirrhosis AND those who are really hard to treat, who have failed on other meds!
One of those blessings we are being blessed with.
Pat
========================================
Can Daklinza profit from a set of niche hep C uses? BMS may soon find out
October 7, 2015 | By Carly Helfand
SHARE
TOOLS
Comment
Contact Author
Reprint
Gilead ($GILD) and AbbVie ($ABBV) may be dominating the hep C field with their next-gen combo treatments, but that doesn't mean there's no room for other companies to sneak in.
Bristol-Myers Squibb ($BMY), for one, is preparing to do just that with Daklinza, a med that Tuesday nabbed the FDA's priority review tag for a trio of new indications in hard-to-treat patients. Regulators will examine the med for use with Gilead's Sovaldi in those who are coinfected with HIV-1, suffering from advanced cirrhosis, or experiencing recurrence of hep C after a liver transplant.
And Bristol has some experience in that department. In July, it won FDA approval for use alongside Sovaldi in patients with difficult-to-treat hep C genotype 3. It also snagged a breakthrough designation from the FDA in May for treating genotype 1 patients with advanced.......
Douglas Manion
"Hepatitis C is not a one-size-fits-all, monolithic disease," Douglas Manion, BMS' head of specialty development, said in a statement. "Our focus for the Daklinza-sofosbuvir regimen centers on addressing the needs of HCV patient subpopulations who need new options even in light of the extraordinary advances that have occurred in HCV treatment."
=======================================
Since I want to be sure and not violate copyright laws, I have included the author, date, article title, and publishing organ.
Great news not only for Gt3s but also for coinfected persons, and/or those with cirrhosis AND those who are really hard to treat, who have failed on other meds!
One of those blessings we are being blessed with.
Pat
Good luck and I am praying for S V R for you and for all!
That 3 months will go quickly. Also ask your dr for Labs at 6 months - just to be doubly sure! : -)
That 3 months will go quickly. Also ask your dr for Labs at 6 months - just to be doubly sure! : -)
Just wanted to tell you I just took my vet last pill!! Now the 3 month wait to see if I am cured. Wish me luck :)
I totally agree! That is why I still follow what is going on with Daklinza - as a Gt 3, that was what my Dr would have used when I became available, but he didn't want to wait to do something to, at least, protect my liver until Dac was available, as I was already F3 and the next step would be cirrhosis. Praise God, I did not need follow up but, as you said, it is good that it is there now.
Good luck in your present treatment so that you won't need the Dac, but....
God bless ................and on to SVR!
Pat
Good luck in your present treatment so that you won't need the Dac, but....
God bless ................and on to SVR!
Pat
Well that's good to read. Good to know that if my current meds don't work for me there is something else to fight gt3 that seems very effective.
OOPS, meant to remove the ad for signing up for their stuff.
Administrator, my bad! If it needs to be removed, please let me know if I can repost the part without the ad?
Administrator, my bad! If it needs to be removed, please let me know if I can repost the part without the ad?
Good news for Hep C Gt3s in the U K!!
Below is quoted dro the Fierce Biotech newsletter of this date (October 16).
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Topics: Sales and Marketing
U.K. cost watchdog gives thumbs-up to Bristol-Myers' hep C drug
October 16, 2015 | By Emily Wasserman
U.K. cost watchdog gives thumbs-up to Bristol-Myers' hep C drug
Bristol-Myers Squibb ($BMY) got a go-ahead from the U.K.'s cost gatekeeper for its chronic hep C med Daklinza (daclatasvir), a win for the company as it finds its place in a fiercely contentious hep C market dominated by Gilead Sciences ($GILD) and AbbVie ($ABBV).
The U.K.'s National Institute for Health and Care Excellence (NICE) signed off on the once-daily pill in combination with other treatments for patients with genotypes 1, 3 and 4 of the disease, backpedaling on an earlier decision in July to exclude genotype 3, a difficult-to-treat form of hep C. About 214,000 people in the U.K. have chronic hep C, and almost half of those patients--or around 100,000--have genotype 3, BMS said in a statement.
Daklinza is already approved in Europe for use with Gilead's Sovaldi to treat genotype 3 of the disease, and the all-oral combo boasts cure rates of up to 100%. But until now, most hep C patients in the U.K. with genotype 3 were restricted to interferon, the company said in a statement, which often comes with painful side effects and does not hold the promise of a cure.
[Webinar] FDA's Expedited Development and Approval Programs
Date: Tuesday, October 20th | 1pm ET / 10am PT
FDA's Breakthrough Therapy, Accelerated Approval, Priority Review, and Fast Track may speed product approval. In this webinar, David Shoemaker will explain the differences, describe strategies to determine which program may be right for you, and discuss FDA requirements for each. Register Now!
Sign up for our FREE newsletter for more news like this sent to your inbox!
"The burden of genotype 3 hepatitis C in the United Kingdom is one of the highest anywhere in Europe," Douglas Manion, BMS' head of specialty development, said in a statement. "England has now joined Italy, France, The Netherlands, Sweden, Belgium, Switzerland, Denmark, Scotland and Ireland" in approving Daclatasvir for the treatment of genotype 3 HCV, he said.
The NICE green light comes as BMS angles for a spot in the hep C market. Gilead and AbbVie already hold a lead with their hep C meds, as Gilead's Harvoni and AbbVie's Viekira Pak gobble up market share.
But BMS has found success working the edges, targeting untapped niches and recently nabbing the FDA's priority review for Daklinza three new indications for hard to treat patients. Regulators will look at how well the med works with Sovaldi to treat individuals who also have HIV-1, advanced cirrhosis or who contract hep C again after a liver transplant. Daklinza is already approved in tandem with Sovaldi to treat genotype 3 patients in the U.S.
"Hepatitis C is not a one-size-fits-all, monolithic disease," Manion said earlier this month. "Our focus for the Daklinza-sofosbuvir regimen centers on addressing the needs of HCV patient subpopulations who need new options even in light of the extraordinary advances that have occurred in HCV treatment."
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Please see the above article for references or bms news for Bristol Myers Squibb's release.
I see that they are joining the US as several countries in Europe using this for Gt3s and also for hard to treat 1s and 4s.
Praying for 100% SVR for all the folks who take it!
Pat
Below is quoted dro the Fierce Biotech newsletter of this date (October 16).
===============================
Topics: Sales and Marketing
U.K. cost watchdog gives thumbs-up to Bristol-Myers' hep C drug
October 16, 2015 | By Emily Wasserman
U.K. cost watchdog gives thumbs-up to Bristol-Myers' hep C drug
Bristol-Myers Squibb ($BMY) got a go-ahead from the U.K.'s cost gatekeeper for its chronic hep C med Daklinza (daclatasvir), a win for the company as it finds its place in a fiercely contentious hep C market dominated by Gilead Sciences ($GILD) and AbbVie ($ABBV).
The U.K.'s National Institute for Health and Care Excellence (NICE) signed off on the once-daily pill in combination with other treatments for patients with genotypes 1, 3 and 4 of the disease, backpedaling on an earlier decision in July to exclude genotype 3, a difficult-to-treat form of hep C. About 214,000 people in the U.K. have chronic hep C, and almost half of those patients--or around 100,000--have genotype 3, BMS said in a statement.
Daklinza is already approved in Europe for use with Gilead's Sovaldi to treat genotype 3 of the disease, and the all-oral combo boasts cure rates of up to 100%. But until now, most hep C patients in the U.K. with genotype 3 were restricted to interferon, the company said in a statement, which often comes with painful side effects and does not hold the promise of a cure.
[Webinar] FDA's Expedited Development and Approval Programs
Date: Tuesday, October 20th | 1pm ET / 10am PT
FDA's Breakthrough Therapy, Accelerated Approval, Priority Review, and Fast Track may speed product approval. In this webinar, David Shoemaker will explain the differences, describe strategies to determine which program may be right for you, and discuss FDA requirements for each. Register Now!
Sign up for our FREE newsletter for more news like this sent to your inbox!
"The burden of genotype 3 hepatitis C in the United Kingdom is one of the highest anywhere in Europe," Douglas Manion, BMS' head of specialty development, said in a statement. "England has now joined Italy, France, The Netherlands, Sweden, Belgium, Switzerland, Denmark, Scotland and Ireland" in approving Daclatasvir for the treatment of genotype 3 HCV, he said.
The NICE green light comes as BMS angles for a spot in the hep C market. Gilead and AbbVie already hold a lead with their hep C meds, as Gilead's Harvoni and AbbVie's Viekira Pak gobble up market share.
But BMS has found success working the edges, targeting untapped niches and recently nabbing the FDA's priority review for Daklinza three new indications for hard to treat patients. Regulators will look at how well the med works with Sovaldi to treat individuals who also have HIV-1, advanced cirrhosis or who contract hep C again after a liver transplant. Daklinza is already approved in tandem with Sovaldi to treat genotype 3 patients in the U.S.
"Hepatitis C is not a one-size-fits-all, monolithic disease," Manion said earlier this month. "Our focus for the Daklinza-sofosbuvir regimen centers on addressing the needs of HCV patient subpopulations who need new options even in light of the extraordinary advances that have occurred in HCV treatment."
=============================
Please see the above article for references or bms news for Bristol Myers Squibb's release.
I see that they are joining the US as several countries in Europe using this for Gt3s and also for hard to treat 1s and 4s.
Praying for 100% SVR for all the folks who take it!
Pat
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