Two important FDA designations are Orphan Drug Status and Special Protocol Assessment. Today we'll discuss the SPA and how it relates to CTP-499. An SPA is a designation from the Food and Drug Administration that an uncompleted phase 3 clinical trials design, clinical endpoints, and statistical analysis are acceptable for FDA approval. Basically means that if the company meets those pre-determined endpoints in the trial, FDA approval should be a very high probability.
We previously wrote about one of Concert's drug for Type 2 Diabetic Nephropathy named CTP-499 here, What is CTP-499. The company has been under negotiations with the FDA for an SPA for that drug for over a year. The CEO has stated that they should have an SPA for CTP-499 by the end of this calendar year. After that, a partnership will be selected, and the costs of the lengthy (three years) trial will be split in some equitable way. The selected partner should feel more comfortable about the trial's design being granted an SPA from the FDA, and there will be one pivotal phase 3 clinical trial, as opposed to two phase 3 trials. The trial's design in this case is a result of the completed phase 2 clinical trial's findings, from a subset of patients and their results vs. placebo. If the phase 3 trial starts the beginning of 2016, lasts three years, and the company files a New Drug Application (NDA) after that, FDA approval could potentially take a year from there. So, by the beginning of 2020, the drug could go to commercialization and have approximately ten years of patent exclusivity.
The patent for CTP-499 runs until 2029 - 2030 in the US, EU, and Japan. The market for Diabetic Nephropathy is estimated to reach $3 billion by 2020 from research here Global Market Study. CTP-499 will be used as co-therapy with ACEI and/or ARB for patients that have advanced to a specified point of disease. Thank you for reading.
We previously wrote about one of Concert's drug for Type 2 Diabetic Nephropathy named CTP-499 here, What is CTP-499. The company has been under negotiations with the FDA for an SPA for that drug for over a year. The CEO has stated that they should have an SPA for CTP-499 by the end of this calendar year. After that, a partnership will be selected, and the costs of the lengthy (three years) trial will be split in some equitable way. The selected partner should feel more comfortable about the trial's design being granted an SPA from the FDA, and there will be one pivotal phase 3 clinical trial, as opposed to two phase 3 trials. The trial's design in this case is a result of the completed phase 2 clinical trial's findings, from a subset of patients and their results vs. placebo. If the phase 3 trial starts the beginning of 2016, lasts three years, and the company files a New Drug Application (NDA) after that, FDA approval could potentially take a year from there. So, by the beginning of 2020, the drug could go to commercialization and have approximately ten years of patent exclusivity.
The patent for CTP-499 runs until 2029 - 2030 in the US, EU, and Japan. The market for Diabetic Nephropathy is estimated to reach $3 billion by 2020 from research here Global Market Study. CTP-499 will be used as co-therapy with ACEI and/or ARB for patients that have advanced to a specified point of disease. Thank you for reading.
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