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Affymax, Inc. Message Board

  • twotonsx twotonsx Jul 1, 2013 8:23 AM Flag

    Good indication Takeda wants Omontys back on the Market

    From the Takeda site. Easy to find, just look. The last paragraph is telling, especially "determination of a risk mitigation plan". Seems to indicate they are more than trying to find the root cause to address litigation but also get it back on the market.

    London, UK, 28 June, 2013 and Osaka, Japan, 1 July, 2013 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that its wholly-owned subsidiary Takeda Development Centre Europe Ltd. has withdrawn the European Marketing Authorization Application (MAA) for peginesatide solution for injection, which was intended to be used for treatment of symptomatic anaemia associated with chronic kidney disease in adult patients undergoing dialysis.

    In February, Takeda voluntarily recalled all lots of peginesatide from the US market as a result of new postmarketing reports of serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.

    While the company has been working actively to investigate the root cause of these hypersensitivity reactions, the investigation is currently ongoing and a root cause analysis and determination of a risk mitigation plan will not be complete during the European MAA procedure timeframe. Therefore Takeda has made the decision to withdraw the European MAA and determine at a later date the appropriate direction for the product.

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    • This is pretty good news. As I said for Takeda it is blockbuster. They are going to provide a solution for the First day reaction. As I said many times they will put forward a Mitigation plan to tackle this First day reaction or apaxalis. Either it might be a preventive check up for allergic reaction or small dosage increments of that sort or a subcutaneous method of administration.

      Something seriously in the works and it is in Takeda's interest to get this in the market place asap.

      They waited till this month and realized even though they might present their version, EMA may not give its go ahead immediately hence go thru FDA first and then go back to EMA after getting FDA nod.

      Remember the trials are still continuing for other indication that too patients are receiving for the PAST 7 YEARS, that is HUGE without any safety concerns.

      Sentiment: Strong Buy

    • Yes. But does Takeda want O back on the market any time soon? Does it want it back on the market soon enough to save AFFY longs? I doubt it.

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