Sun, Jul 13, 2014, 9:29 AM EDT - U.S. Markets closed

Recent

% | $
Quotes you view appear here for quick access.

Aeterna Zentaris Inc. Message Board

  • strongbuy33 strongbuy33 Oct 20, 2012 9:00 PM Flag

    SVNT got EU approval on Oct-19... All in

    18 October 2012
    EMA/CHMP/672303/2012
    Committee for Medicinal Products for Human Use (CHMP)
    Summary of opinion1 (initial authorisation)
    Krystexxa
    pegloticase
    On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Krystexxa, 8 mg/ml, concentrate for solution for infusion intended for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated. The applicant for this medicinal product is Savient Pharma Ireland Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
    The active substance of Krystexxa is pegloticase, an other antigout preparation (M04AK02) and is a polyethylene glycol (PEG)-modified recombinant mammalian uricase of the therapeutic class bio-uricolytic agent that reduce serum uric acid.
    The benefits with Krystexxa are its ability to reduce serum uric acid undetectable level in patients who have failed to respond to conventional urate-lowering therapy (xanthine oxidase inhibitors or uricosuric agents). The most common side effects are infusion reactions/anaphylactic reactions, serious cardiac events, and gout flares have been identified.
    A pharmacovigilance plan for Krystexxa will be implemented as part of the marketing authorisation.
    The approved indication is: "Krystexxa is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated (see section 4.4). The decision to treat with Krystexxa should be based on an on-going assessment of the benefits and risks for the individual patient (see section 4.4)." It is proposed that treatment with Krystexxa should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of severe refractory chronic gout.
    1 Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

    Sentiment: Strong Buy

 
AEZS
1.25+0.02(+1.63%)Jul 11 3:59 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.
Potbelly Corporation
NasdaqGSFri, Jul 11, 2014 4:00 PM EDT
DHT Holdings, Inc.
NYSEFri, Jul 11, 2014 4:03 PM EDT