Does anybody know about EU opinion concerning Omontys and the impact given the recall. Takeda did file a marketing authorization application and $5 million milestone is owed to Affy upon acceptance.I hope we will have an update of the recall and ongoing meeting or discussion between Takeda/Affy and FDA prior EMA decision.Any contribution is highly appreciated.
I am going to ask you an honest question, and I hope (LOL) that I get an honest response. Under all of the circumstances, do Longs really believe that Europe will approve Omontys? If you believe it will be approved, please tell us why and how the actual patient usage results are somehow irrelevant.
Here's an excerpt from the FDA after Omontys approval "“Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections.”
Two randomized, active-controlled, open-label, multi-center clinical trials demonstrated the safety and efficacy of Omontys in patients with CKD who were on dialysis. The trials randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either Omontys once monthly or to continue their current ESA (epoetin) treatment. Results showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter.
The most common side effects observed in 10 percent or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure (hypertension) and joint, back, leg or arm pain (arthralgia).
Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer–related anemia, according to the FDA-approved labeling. It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with CKD on dialysis.
The FDA approved Omontys with a Risk Evaluation and Mitigation Strategy (REMS), which added safety measures consisting of educational elements for health care professionals and a requirement to assess drug use data."
So why not in Europe because some of the hospitals (in France for instance) were parts of the Phase 3 trial.
I know its going to be a waste of my time to bring any FACTS into this discussion because you just hate to be bothered by such pesky details, but here we go.
There are several ESA's on the European market that work similarly to EPOGEN and OMONTYS. They stimulate the production of red bloods cells, etc. The only down side to those drugs are that the blood work has to be done on a biweekly basis due to the fact that the half life of the drugs is significantly HIGHER. This reason has caused the FDA to reject NDA application for these drugs, including biosimilars in the US.
The Half life is the amount of time that it takes the body to eliminate 50% of the active form of the drug, to stop producing the therapeutic effect. EPOGEN has a half life of 4 to 13 hours in patients without kidney failure and takes approx 20% longer with CKD patients. For OMONTYS, the mean half-life in dialysis patients is approximately 47.9 ± 16.5 hours following IV dose, longer for subcutaneous injection. This is why OMONTYS requires once per month dose and Epogen requires multiple.
Its a double edged sword, it works better in the sense that with one dose you get a significant therapeutic response but a significant increase in red blood cells & Hemaglobin level 11 g/dl makes patient high risk for Cardiac Events and MI. This is why the only clinical Indication for CKD patients is Dialysis patients with Anemia ONLY.
The safety profile for the current EU drugs is much worse compared to OMONTYS and EPOGEN who are both Black Boxed by the FDA and in recent years have become very strict on how low H/H levels have to be before initiation of ESA treatment.
In conclusion, OMONTYS will be approved in EU as it has already been approved in JAPAN. ESA's are dangerous drugs and its all about risk/benefit ratio. Patients can be tested for allergy to the drug prior to administration, it just wasn't part of the protocol so far with OMONTYS. I believe it will be instituted upon re-marketing.