U.S. FDA approves AbbVie all-oral hepatitis C treatment# Stock
d*8
1 楼
U.S. FDA approves AbbVie all-oral hepatitis C treatment
d*8
2 楼
Dec 19 (Reuters) - U.S. health regulators on Friday approved AbbVie's all-
oral treatment for hepatitis C, providing the first competition for Gilead
Sciences huge selling and expensive medicine for the liver-destroying virus.
The AbbVie regimen consists of four different anti-viral drugs to be taken
as three pills in the morning and one in the evening. The U.S. Food and Drug
Administration approved the regimen, which will be sold under the brand
name Viekira Pak, for patients with genotype 1 form of the virus, the most
common type of hepatitis C and the most difficult to treat.
Gilead's Sovaldi, which was approved a year ago, had been selling at the
rate of about $3 billion per quarter due to huge pent up demand. Sovaldi is
now combined with another Gilead drug and sold as Harvoni, which is taken as
one pill once a day for 12 weeks at a cost of about $94,500. Some patients
can take it for just eight weeks, which costs about $63,000.
The AbbVie regimen has demonstrated similarly impressive efficacy to Gilead'
s, with cure rates above 90 percent, and minimal negative side effects.
But Gilead, which has come under intense pressure from U.S. health insurers,
politicians and pharmacy benefit managers over the high cost of its
treatment, is widely expected to dominate the market, given its convenience
advantage of fewer pills and drugs, unless AbbVie undercuts Harvoni on
pricing.
(Reporting by Bill Berkrot and Caroline Humer; Editing by Chizu Nomiyama)
oral treatment for hepatitis C, providing the first competition for Gilead
Sciences huge selling and expensive medicine for the liver-destroying virus.
The AbbVie regimen consists of four different anti-viral drugs to be taken
as three pills in the morning and one in the evening. The U.S. Food and Drug
Administration approved the regimen, which will be sold under the brand
name Viekira Pak, for patients with genotype 1 form of the virus, the most
common type of hepatitis C and the most difficult to treat.
Gilead's Sovaldi, which was approved a year ago, had been selling at the
rate of about $3 billion per quarter due to huge pent up demand. Sovaldi is
now combined with another Gilead drug and sold as Harvoni, which is taken as
one pill once a day for 12 weeks at a cost of about $94,500. Some patients
can take it for just eight weeks, which costs about $63,000.
The AbbVie regimen has demonstrated similarly impressive efficacy to Gilead'
s, with cure rates above 90 percent, and minimal negative side effects.
But Gilead, which has come under intense pressure from U.S. health insurers,
politicians and pharmacy benefit managers over the high cost of its
treatment, is widely expected to dominate the market, given its convenience
advantage of fewer pills and drugs, unless AbbVie undercuts Harvoni on
pricing.
(Reporting by Bill Berkrot and Caroline Humer; Editing by Chizu Nomiyama)
d*8
3 楼
$GILD @adamfeuerstein 9m9 minutes [email protected] Buyside “consensus
” on $ABBV price is ~ 15-20% discount to $GILD, per @MarkSchoenebaum
” on $ABBV price is ~ 15-20% discount to $GILD, per @MarkSchoenebaum
m*e
4 楼
还有疗程。一共要花多少钱
consensus
【在 d******8 的大作中提到】
: $GILD @adamfeuerstein 9m9 minutes [email protected] Buyside “consensus
: ” on $ABBV price is ~ 15-20% discount to $GILD, per @MarkSchoenebaum
consensus
【在 d******8 的大作中提到】
: $GILD @adamfeuerstein 9m9 minutes [email protected] Buyside “consensus
: ” on $ABBV price is ~ 15-20% discount to $GILD, per @MarkSchoenebaum
C*T
5 楼
好像gild没有受什么影响
d*8
6 楼
The regimen consists of several pills taken daily for about 12 weeks,
s*r
7 楼
cure rates above 90 percent?
If it can be cured, 100K is still very acceptable.
If it can be cured, 100K is still very acceptable.
d*8
8 楼
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm42
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir
, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to
treat patients with chronic hepatitis C virus (HCV) genotype 1 infection,
including those with a type of advanced liver disease called cirrhosis.
Hepatitis C is a viral disease that causes inflammation of the liver that
can lead to reduced liver function, liver failure or liver cancer. Most
people infected with HCV have no symptoms of the disease until liver damage
becomes apparent, which may take decades. According to the Centers for
Disease Control and Prevention, about 3.2 million Americans are infected
with HCV, and without proper treatment, 15-30 percent of these people will
go on to develop cirrhosis.
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir
—that work together to inhibit the growth of HCV. It also contains
ritonavir, a previously approved drug, which is used to increase blood
levels of paritaprevir. Viekira Pak can be used with or without ribavirin,
but it is not recommended for patients whose liver is unable to function
properly (decompensated cirrhosis).
“The new generation of therapeutics for hepatitis C virus is changing the
treatment paradigm for Americans living with the disease,” said Edward Cox,
M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’
s Center for Drug Evaluation and Research. “We continue to see the
development of new all-oral treatments with very high virologic response
rates and improved safety profiles compared to some of the older interferon-
based drug regimens.”
Viekira Pak is the fourth drug product approved by the FDA in the past year
to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in
November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir
and sofosbuvir) in October 2014.
Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308
participants with chronic HCV infection with and without cirrhosis. In
different trials, participants were randomly assigned to receive Viekira Pak
or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira
Pak with ribavirin for 12 or 24 weeks.
The trials were designed to measure whether the hepatitis C virus was no
longer detected in the blood at least 12 weeks after finishing treatment (
sustained virologic response, or SVR), indicating that a participant’s HCV
infection has been cured. Results from multiple populations, including those
considered difficult to treat, showed 91 to 100 percent of participants who
received Viekira Pak at the recommended dosing achieved SVR. The
recommended dosing for Viekira Pak is two ombitasvir, paritaprevir,
ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one
dasabuvir 250 mg tablet twice daily.
The most common side effects reported in clinical trial participants were
feeling tired, itching, feeling weak or lack of energy, nausea and trouble
sleeping.
Viekira Pak is the eleventh new drug product with breakthrough therapy
designation to receive FDA approval. The FDA can designate a drug as a
breakthrough therapy at the request of the sponsor if preliminary clinical
evidence indicates the drug may demonstrate a substantial improvement over
available therapies for patients with serious or life-threatening diseases.
Viekira Pak was reviewed under the FDA’s priority review program, which
provides for an expedited review of drugs that treat serious conditions and,
if approved, would provide significant improvement in safety or
effectiveness.
Viekira Pak is marketed by AbbVie Inc., based in North Chicago, Illinois.
Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals.
Sovaldi and Harvoni are marketed by Gilead Sciences, based in Foster City,
California.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is responsible
for the safety and security of our nation’s food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
###
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir
, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to
treat patients with chronic hepatitis C virus (HCV) genotype 1 infection,
including those with a type of advanced liver disease called cirrhosis.
Hepatitis C is a viral disease that causes inflammation of the liver that
can lead to reduced liver function, liver failure or liver cancer. Most
people infected with HCV have no symptoms of the disease until liver damage
becomes apparent, which may take decades. According to the Centers for
Disease Control and Prevention, about 3.2 million Americans are infected
with HCV, and without proper treatment, 15-30 percent of these people will
go on to develop cirrhosis.
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir
—that work together to inhibit the growth of HCV. It also contains
ritonavir, a previously approved drug, which is used to increase blood
levels of paritaprevir. Viekira Pak can be used with or without ribavirin,
but it is not recommended for patients whose liver is unable to function
properly (decompensated cirrhosis).
“The new generation of therapeutics for hepatitis C virus is changing the
treatment paradigm for Americans living with the disease,” said Edward Cox,
M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’
s Center for Drug Evaluation and Research. “We continue to see the
development of new all-oral treatments with very high virologic response
rates and improved safety profiles compared to some of the older interferon-
based drug regimens.”
Viekira Pak is the fourth drug product approved by the FDA in the past year
to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in
November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir
and sofosbuvir) in October 2014.
Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308
participants with chronic HCV infection with and without cirrhosis. In
different trials, participants were randomly assigned to receive Viekira Pak
or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira
Pak with ribavirin for 12 or 24 weeks.
The trials were designed to measure whether the hepatitis C virus was no
longer detected in the blood at least 12 weeks after finishing treatment (
sustained virologic response, or SVR), indicating that a participant’s HCV
infection has been cured. Results from multiple populations, including those
considered difficult to treat, showed 91 to 100 percent of participants who
received Viekira Pak at the recommended dosing achieved SVR. The
recommended dosing for Viekira Pak is two ombitasvir, paritaprevir,
ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one
dasabuvir 250 mg tablet twice daily.
The most common side effects reported in clinical trial participants were
feeling tired, itching, feeling weak or lack of energy, nausea and trouble
sleeping.
Viekira Pak is the eleventh new drug product with breakthrough therapy
designation to receive FDA approval. The FDA can designate a drug as a
breakthrough therapy at the request of the sponsor if preliminary clinical
evidence indicates the drug may demonstrate a substantial improvement over
available therapies for patients with serious or life-threatening diseases.
Viekira Pak was reviewed under the FDA’s priority review program, which
provides for an expedited review of drugs that treat serious conditions and,
if approved, would provide significant improvement in safety or
effectiveness.
Viekira Pak is marketed by AbbVie Inc., based in North Chicago, Illinois.
Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals.
Sovaldi and Harvoni are marketed by Gilead Sciences, based in Foster City,
California.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is responsible
for the safety and security of our nation’s food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
###
s*r
9 楼
美帝还是牛鼻啊，这都能搞定。
不过，对这个CURE俺还是很怀疑。12 周检测不到就算治愈， 俺觉得两年比较合适。
ombitasvir
to
damage
【在 d******8 的大作中提到】
: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm42
: The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir
: , paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to
: treat patients with chronic hepatitis C virus (HCV) genotype 1 infection,
: including those with a type of advanced liver disease called cirrhosis.
: Hepatitis C is a viral disease that causes inflammation of the liver that
: can lead to reduced liver function, liver failure or liver cancer. Most
: people infected with HCV have no symptoms of the disease until liver damage
: becomes apparent, which may take decades. According to the Centers for
: Disease Control and Prevention, about 3.2 million Americans are infected
不过，对这个CURE俺还是很怀疑。12 周检测不到就算治愈， 俺觉得两年比较合适。
ombitasvir
to
damage
【在 d******8 的大作中提到】
: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm42
: The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir
: , paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to
: treat patients with chronic hepatitis C virus (HCV) genotype 1 infection,
: including those with a type of advanced liver disease called cirrhosis.
: Hepatitis C is a viral disease that causes inflammation of the liver that
: can lead to reduced liver function, liver failure or liver cancer. Most
: people infected with HCV have no symptoms of the disease until liver damage
: becomes apparent, which may take decades. According to the Centers for
: Disease Control and Prevention, about 3.2 million Americans are infected
j*8
10 楼
跌了，sell on news?
j*8
11 楼
有detail了吗？
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