Omontys is a ESA, there are others on the market approved for CKD/Hemodialysis.
1. Omontys is only approved for Hemodialysis patients.
2. You have Epogen/Aranesp which can be used in both CKD/HD patients. So as it currently stands with FDA approval. Omontys only approved for Hemodialysis patients.
3. Good thing about Omontys is its once a month dosage. Where as epogen is 3x week with each HD
4.As far as reactions are concerned, i have not read the new data about hypersensitivity reactions with Omontys. Label already says hypersensitivity reactions are possible. Question is what is the truth. Did Omontys fudge the numbers initially to get approval? or is the new study fudging numbers? How big was the new study? You need to show strength in numbers. Who sponsored the new study?.
5. Lets says everything with the new study is correct. AFFY needs to look into the root cause, is it a preservative that is causing it? or is it really the drug. Did is only occur in certain subset of patient population?
6. There is also a issue with bundling in HD patients. Most HD patients are medicare paid. Govt has said that for each HD session, you will get a set amount of $ for each patient. That includes all meds a HD patient is to receive (ESA, Iron, Zemplar) I do not know what the cost of Omontys is. We use epogen at our center.
7. As a MD for a patient in the US where one is always worried about being sued for something. For now i think most nephrologist will stay away from Omontys based on the publicity it has received. BECAUSE THERE IS AN ALTERNATIVE. SO WHY TAKE THE CHANCE. IF YOU WERE A PATIENT WHICH DRUG WOULD YOU PREFER?
8. Now i am not saying its all bad news for Omontys. Can they get approval for CKD patients? if so that changes the entire realm of things. How about cancer patients with anemia? Also so what if Omontys is pulled of shelf in the US. There is Europe/ASIA/CANADA physician litigation is completely different as is patient pop.
So what you're saying is AFFY might have fudged the number? That mean most of the drug FDA approved are public fudged, especial pain killer.
Godwinpeak, give it up man. Come on, 25,000 yes, 25k not 2,500. It has nothing to do with Monty period.
you would be surprised how data can be manipulated. Poor accounting numbers can be fudged to look good, so why not statistics. There is an entire profession dedicated to statistics. I am not saying they did, but plenty of drug companies in the past have hidden the truth.
Doc. I am a retired health care lawyer and hospital general counsel with over 30 years of practice. I have researched O on the internet with available resources. I would like you to please read my posts, Why Omontys Will Never Return to Market and Affymax Headed to Bankruptcy [Part 1 and Part 2] and give me your thoughts. To me the key to Omontys demise is the PEARL studies, which Affymax itself described as "inexplicable" and a disastrous patient safety profile "for which there is no definitive answer." What are your thoughts. If you are who you say you are I would value your opinion.
Stop posting your credentials. You are a cut and paste champion. I see very little original thought from you. You know I am an attorney as well and frankly, you do not impress me. Stop posting your G.D. credentials (genuine or not) you professional basher.
i cannot comment on the business aspect of things. All i will say is there are other options available to a nephrologist. Omontys is not the only ESA on the market. However rules are different in other parts of the world. Tons of drugs used in europe/asia which will never be approved in the US due to side effect profiles. They way AFFY management is behaving, they surely do not seem confident in their own product.