Re: BioSpace-Amgen's Repatha
in response to
by
posted on
Nov 16, 2017 10:43AM
And just to add onto what BKC wrote, Repatha did not reduce cardiovascular death. Recall when Jardiance/empagliflozin cardiovascular outcomes in the EMPA-REG OUTCOME trial were revealed, there was a standing ovation not so much for the significant reduction in 3-point MACE (14% RRR), but for the 38% RRR in cardiovascular death and 32% RRR in death from any cause.
Personally, I think the viability of the PCSK9 antibody drugs will be short-lived. In my opinion, Esperion's bempedoic acid small molecule ATP-citrate lyase inhibitor is going to take a huge chunk out of this market if and when its Phase 3 LDL-lowering trials wrap up next year and especially if and when its Phase 3 cardiovascular outcomes trial wraps up ~2022. PCSK9 therapies only target LDL. Bempedoic acid not only lowers LDL but also has a very pronounced anti-inflammatory effect to decrease hsCRP. So based on what we saw with the CANTOS trial, the expectation is that bempedoic acid will have the two-pronged effect of LDL-lowering and anti-inflammatory.
Also in the pipeline for Alnylam and The Medicine's company is a RNAi approach (inclisiran) to knock down PCSK9. It could be equally if not more effective than the PCSK9 antibody approaches. Although it is also an injection like the PCSK9 antibodies, in trials so far it seems that the efficacy of a single dose lasts longer than the PCSK9 antibodies. So the price point for inclisiran RNAi approach could be lower than that of the PCSK9 antibody therapies. This one is still a ways off since the Phase 3 LDL lowering trial just started and won't be wrapped up until 2019 and the Phase 3 cardiovascular outcomes trial hasn't been announced yet. And FYI, Kausik Ray is also principal investigator this.
BDAZ