Al­ny­lam up­dates its pitch for ex­pand­ed On­pat­tro la­bel with 18-month PhI­II da­ta

Al­ny­lam Phar­ma­ceu­ti­cals is so pleased with 18-month da­ta from its Phase III tri­al in­ves­ti­gat­ing On­pat­tro as a treat­ment of AT­TR car­diomy­opa­thy that it sub­mit­ted it as an amend­ment to its sN­DA as an­a­lysts ex­pect ap­proval lat­er this year with the da­ta strength­en­ing the ap­pli­ca­tion.

The tri­al, dubbed APOL­LO-B, in­ves­ti­gat­ed the drug’s im­pact on the qual­i­ty of life in pa­tients with AT­TR amy­loi­do­sis against a place­bo. At the 12-month dou­ble-blind­ed (DB) as­sess­ment, the tri­al al­ready hit its pri­ma­ry end­point, which looked at the six-minute walk test in pa­tients tak­ing the drug against a place­bo.

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