A new PCSK9 player draws rave reviews for inclisiran. Can a marketing war with Amgen be far behind?
The Medicines Company $MDCO waded directly into the middle of one of the most bitterly contested fields in biopharma today using a detailed set of efficacy and safety data from their Phase III study of inclisiran to build a case that their drug can whip 3 heavyweight rivals deep into the troubled PCSK9 game.
Just don’t expect the new CEO running things at the company to say much about that rivalry.
Top-lined a few days ago, the efficacy numbers posted at the European Society of Cardiology’s ESC Congress in Paris line up where the analysts had hoped, with a 54% relative reduction in LDL tied to the drug arm compared to placebo — which ranks up there with the high 50s hit by Repatha (Amgen) and Praluent (Regeneron and Sanofi). Just as importantly, the safety data on exhibit Monday look pristine, with an adverse event profile that tends to mirror the control arm along with no evidence of added toxicity — a feature that will encourage everyone in RNAi to go deeper into diseases with massive patient populations after establishing themselves in rare diseases.
There’s even some exploratory cardio data — which will have to be confirmed in a huge, ongoing outcomes study — to help back up their expectations for a competitive benefit on MACE and strokes that payers will want to see proved beyond a reasonable doubt.
The numbers back up a good set of odds on a near-term OK for inclisiran in 2020, provided a nasty surprise isn’t in wait along the sidelines. If so, they’ll be readying a rollout now that will take aim against two of the most touted drugs that ever fell far short of their mark.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 73,100+ biopharma pros reading Endpoints daily — and it's free.