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Besremi
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Besremi versus Pegasys
The Proud-pv study for
Besremi
did not include et/pv patients with enlarged spleens while the Pegasys study did include enlarged spleen patients. Here in the US we are waiting for
Besremi
approval, Pegasys is already approved.
The Proud-pv study for
Besremi
did not include et/pv patients with enlarged spleens while the Pegasys study did include enlarged spleen patients. Here in the US we are waiting for
Besremi
approval, Pegasys is already approved.
Flynn2107
in
MPN Voice
3 years ago
Anyone on Ropeginterferon (Besremi)?
Wondering if anyone has switched from Pegasys (peginterferon) to
Besremi
(ropeginterferon)? I’ve read that side effects, particularly fatigue, are less on
Besremi
so would be interested in giving it a go if that’s the case. Thanks, Sarah 🙂
Wondering if anyone has switched from Pegasys (peginterferon) to
Besremi
(ropeginterferon)? I’ve read that side effects, particularly fatigue, are less on
Besremi
so would be interested in giving it a go if that’s the case. Thanks, Sarah 🙂
IrishSarah
in
MPN Voice
3 years ago
U.S. FDA Accepts PharmaEssentia’s BLA Resubmission for Besremi
The FDA has assigned a six-month review period for the resubmitted application and provided November 13, 2021 as the target Prescription Drug User Fee Act (PDUFA) action date. https://www.businesswire.com/news/home/20210603005908/en/U.S.-FDA-Accepts-PharmaEssentia%E2%80%99s-BLA-Resubmission-for-ropeginterferon-alfa
The FDA has assigned a six-month review period for the resubmitted application and provided November 13, 2021 as the target Prescription Drug User Fee Act (PDUFA) action date. https://www.businesswire.com/news/home/20210603005908/en/U.S.-FDA-Accepts-PharmaEssentia%E2%80%99s-BLA-Resubmission-for-ropeginterferon-alfa
Manouche
in
MPN Voice
3 years ago
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Update 5.0
If
Besremi
does not get authorized, I will start on Pegasys then shift to
Besremi
when it does get FDA approved. I also saw the nephrologist yesterday to review the possible chronic kidney disease. She agrees that something is wrong, but that it is not an immediate threat.
If
Besremi
does not get authorized, I will start on Pegasys then shift to
Besremi
when it does get FDA approved. I also saw the nephrologist yesterday to review the possible chronic kidney disease. She agrees that something is wrong, but that it is not an immediate threat.
hunter5582
in
MPN Voice
3 years ago
Starting Besremi
I hope to be on
Besremi
long term so I will post regular updates on how things progress.
I hope to be on
Besremi
long term so I will post regular updates on how things progress.
JohnSC
in
MPN Voice
3 years ago
FDA Rejects Ropeginterferon alfa-2b for Polycythemia Vera
Although their drug ropeginterferon alfa-2b is sold in the European Union as
Besremi
, the FDA has rejected the approval request for use in the United States.
Although their drug ropeginterferon alfa-2b is sold in the European Union as
Besremi
, the FDA has rejected the approval request for use in the United States.
Manouche
in
MPN Voice
3 years ago
Email to the CEO of the MHRA - please also email this lady
Having done some research I read that
Besremi
Ropeginterferon Alfa-2b has been deemed safe and efficacious in the US ( as of 15/03/2021) as it has also in Europe. I wonder therefore why this drug is not licensed for use in the UK?
Having done some research I read that
Besremi
Ropeginterferon Alfa-2b has been deemed safe and efficacious in the US ( as of 15/03/2021) as it has also in Europe. I wonder therefore why this drug is not licensed for use in the UK?
Loubprv
Volunteer
in
MPN Voice
3 years ago
PTG-300 Clinical Trial Status
I am also interested in
Besremi
, which is nearing FDA approval in the USA. I think the research on the use of
Besremi
in low-risk PV is very promising. Technically I am not low risk, since I am age 65 and have some cooccurring medical conditions.
I am also interested in
Besremi
, which is nearing FDA approval in the USA. I think the research on the use of
Besremi
in low-risk PV is very promising. Technically I am not low risk, since I am age 65 and have some cooccurring medical conditions.
hunter5582
in
MPN Voice
3 years ago
PharmaEssentia starting to promote Besremi
Check out pvsource.com. They are promoting ropeg INF to the medical community. There is an interesting video and you can register for email updates. The company must think FDA approval is immanent. The site is obviously targeting the US market.
Check out pvsource.com. They are promoting ropeg INF to the medical community. There is an interesting video and you can register for email updates. The company must think FDA approval is immanent. The site is obviously targeting the US market.
charl17
in
MPN Voice
3 years ago
AOP Orphan announces 5-year results on BESREMi® in PV at the ASH Annual Meeting 2020
* Freedom of phlebotomy with hematocrit below 45% was achieved in 81.8% of patients receiving
Besremi
vs. only 63.2% in the control group (p=0.01).
* Freedom of phlebotomy with hematocrit below 45% was achieved in 81.8% of patients receiving
Besremi
vs. only 63.2% in the control group (p=0.01).
Manouche
in
MPN Voice
4 years ago
Peginterferon /Besremi and Anxiety issues
He suggested l switch over to
Besremi
. I have to see a Psychiatrist as it is protocol here for everyone on Peg/
Besremi
.
He suggested l switch over to
Besremi
. I have to see a Psychiatrist as it is protocol here for everyone on Peg/
Besremi
.
Dovme
in
MPN Voice
4 years ago
Long-Term Use of Besremi in Polycythemia Vera: 5-Year Results from a Randomized Controlled Study and Its Extension
Ropeginterferon alpha-2b (
BESREMi
®; hereafter ropeg) may ultimately modify the natural history of PV by selectively targeting the malignant clone.
Ropeginterferon alpha-2b (
BESREMi
®; hereafter ropeg) may ultimately modify the natural history of PV by selectively targeting the malignant clone.
Manouche
in
MPN Voice
4 years ago
Besremi: Efficacy and Safety in Different Age Groups
« In summary, after 24 months ropeginterferon induced higher hematological and molecular response rates and higher maintenance of response than HU in PV patients in the age groups < 60 years and ≥60 years, with the latter consisting of a majority of patients between 60 and 70 years of age and only a
« In summary, after 24 months ropeginterferon induced higher hematological and molecular response rates and higher maintenance of response than HU in PV patients in the age groups < 60 years and ≥60 years, with the latter consisting of a majority of patients between 60 and 70 years of age and only a
Manouche
in
MPN Voice
4 years ago
ICC ruled in favor of AOP Orphan Pharmaceuticals AG in arbitration proceedings pertaining to BESREMi®
«After two and a half years of arbitration proceedings concerning
BESREMi
® (Ropeginterferon alfa-2b), the decision by the ICC Arbitral Tribunal has now been made. In 2017 PharmaEssentia had attempted to terminate the contractual agreement with AOP Orphan.
«After two and a half years of arbitration proceedings concerning
BESREMi
® (Ropeginterferon alfa-2b), the decision by the ICC Arbitral Tribunal has now been made. In 2017 PharmaEssentia had attempted to terminate the contractual agreement with AOP Orphan.
Manouche
in
MPN Voice
4 years ago
ICC ruled in favor of AOP Orphan Pharmaceuticals AG in arbitration proceedings pertaining to BESREMi®
«We are relieved that the ICC ruling compensates AOP Orphan now for the delay in getting
BESREMi
® approved in the European Union, and the delay in bringing this important medication to the patients suffering from polycythaemia vera, a rare and chronic disease of the blood building cells", explains Dr
«We are relieved that the ICC ruling compensates AOP Orphan now for the delay in getting
BESREMi
® approved in the European Union, and the delay in bringing this important medication to the patients suffering from polycythaemia vera, a rare and chronic disease of the blood building cells", explains Dr
Manouche
in
MPN Voice
4 years ago
Update 4.0
Likewise approval for
Besremi
. I imagine at some point I will opt for that as well. Of coarse, in the near-term, approval for the COVID vaccines would be really great. I will be getting my vaccine as soon as it is available.
Likewise approval for
Besremi
. I imagine at some point I will opt for that as well. Of coarse, in the near-term, approval for the COVID vaccines would be really great. I will be getting my vaccine as soon as it is available.
hunter5582
in
MPN Voice
4 years ago
Longterm Interferon treatment
The drug of choice I am inclined to initially try is pegylated interferon, either pegasys or
besremi
, if available in the US soon. I am calling on patients who have used and/or are still using interferon. How does/ did it work for you? What were your side effects and quality of life?
The drug of choice I am inclined to initially try is pegylated interferon, either pegasys or
besremi
, if available in the US soon. I am calling on patients who have used and/or are still using interferon. How does/ did it work for you? What were your side effects and quality of life?
Loooonglife
in
MPN Voice
4 years ago
BESREMi Ropeginterferon alfa-2b is available in Austria and Germany
After hearing very encouraging information regarding effectiveness of
BESREMi
Ropeginterferon alfa-2b from the doctor in my local clinic (based on clinical trial they run for several years) I checked the price in Austrian drug store.
After hearing very encouraging information regarding effectiveness of
BESREMi
Ropeginterferon alfa-2b from the doctor in my local clinic (based on clinical trial they run for several years) I checked the price in Austrian drug store.
Alexbits
in
MPN Voice
5 years ago
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