Wed, Jul 23, 2014, 6:53 PM EDT - U.S. Markets closed

Recent

% | $
Click the to save as a favorite.

Affymax, Inc. (AFFY) Message Board

  • dinepat203 dinepat203 Mar 28, 2013 3:13 PM Flag

    AFFY SURVIVED

    All lots of Omontys (peginasetide) sold in 10mg and 20mg vials have been recalled, said the two companies, who noted that the patients died after receiving first-dose intravenous injection with the drug.

    There have been no reports of such reactions following subsequent dosing in patients who have completed their dialysis session, or in patients receiving the drug subcutaneously, although Affymax noted that the number of patients receiving it subcutaneously remains limited.

    The fatalities appear to have been caused by serious allergic reactions - including anaphylaxis - and Takeda and Affymax have warned healthcare providers not to prescribe Omontys while the root cause is being investigated.

    The records of the patients who died are being examined to see if there is any common characteristic that could explain the reactions, while manufacturing, the handling of the product in the supply chain and practices at dialysis centres where the drug was administered are also being examined.

    On a conference call, Affymax chief medical officer Anne-Marie Duliege noted that 25,000 patients have been treated with Omontys since launch, with hypersensitivity reactions seen in 0.2% of cases. This was about the same rate as seen in clinical trials, but the seriousness of the reactions was considerably less during testing, she added.

    Clinical testing was carried out on single-dose vials, and the reactions have occurred among patients treated with Omontys taken from multidose vials, but Affymax stressed on the call that it is too early to speculate on possible manufacturing issues or other causes.

    Omontys was launched in the US less than a year ago as the first competitor to Amgen's Epogen (epoetin alfa) blockbuster, and achieved sales of around $15 million in the third quarter of 2012, according to Takeda

    SortNewest  |  Oldest  |  Most Replied Expand all replies
 
AFFY
0.100.00(-1.48%)Jul 23 3:24 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.