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April 2, 2014
08:08 EDTALNYAlnylam receives positive opinion for orphan drug designation ALN-TTRsc
Alnylam Pharmaceuticals announces that the European Medicines Agency Committee for Orphan Medicinal Products has adopted a positive opinion recommending ALN-TTRsc for designation as an orphan medicinal product for the treatment of transthyretin-mediated amyloidosis. ALN-TTRsc is currently in a pilot Phase 2 clinical trial for the treatment of ATTR patients with TTR cardiac amyloidosis; this study is aimed at evaluating the tolerability of ALN-TTRsc in approximately 15 patients. In addition, the study will assess preliminary clinical activity as measured by knockdown of serum TTR levels and additional exploratory tests, such as cardiac imaging, circulating cardiac biomarkers, 6-minute walk test, New York Heart Association classification, and measures of heart failure symptoms and quality of life. The company expects to present data from the Phase 2 trial in late 2014. Patients completing the Phase 2 trial will be eligible to participate in an open-label extension study for further assessment of general tolerability and clinical activity with long-term dosing; the ALN-TTRsc Phase 2 OLE study is expected to be initiated in mid-2014. Assuming positive results, Alnylam expects to begin a Phase 3 trial in TTR cardiac amyloidosis patients by the end of 2014.
News For ALNY From The Last 14 Days
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May 26, 2015
13:19 EDTALNYAlnylam management to meet with Needham
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08:14 EDTALNYBoston Biotech Conferences to hold a conference
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08:06 EDTALNYAlnylam initiates Phase 1 ALN-AS1 trial
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May 20, 2015
07:04 EDTALNYAlnylam receives orphan drug designation for revusiran
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May 19, 2015
11:03 EDTALNYAlnylam transthyretin amyloidosis treatment designated for FDA orphan status
Alnylam's revusiran was designated by the FDA for orphan drug status as a treatment of transthyretin amyloidosis. Reference Link
07:28 EDTALNYUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
May 17, 2015
15:24 EDTALNYAlnylam files ALN-AAT trial application, reports positive results in primates
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