Sanofi, Alnylam Report Positive Patisiran Phase III Trial, First-Ever for RNAi Therapeutic
September 20 2017 - 9:11AM
Dow Jones News
By Sonia Amaral Rohter
Sanofi SA (SAN.FR) and Alnylam Pharmaceuticals Inc. (ALNY)
reported Wednesday that Patisiran met all primary and secondary
endpoints in a Phase III trial of its use against a rare, inherited
disorder.
The trial looked at the use of Patisiran in patients with
hereditary transthyretin-mediated amyloidosis, a progressively
debilitating disease in which a gene mutation causes the production
of a type of abnormal protein that accumulates in body organs and
tissues, damaging them. Patisiran is designed to target and silence
the mechanism that leads to production of this protein.
Patisiran is part of a class of medicines called RNA
interference, or RNAi, therapeutics that aim to inhibit the
expression of certain genes in order to treat or prevent
disease.
Alnylam Chief Executive John Maraganore said: "We are very proud
to report the first-ever positive Phase III results for an RNAi
therapeutic, marking the potential arrival of an entirely new class
of medicines."
Alnylam said it would file a new drug application with the U.S.
Food and Drug Administration in late 2017. Should the company
receive regulatory approval, Alnylam will commercialize Patisiran
in the U.S., Canada and Western Europe, while Sanofi Genzyme will
commercialize the product in the rest of the world.
The full results of the trial will be presented on November
2.
Write to Sonia Amaral Rohter at
sonia.amaralrohter@dowjones.com
(END) Dow Jones Newswires
September 20, 2017 08:56 ET (12:56 GMT)
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