Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) Q4 2022 Earnings Call Transcript

Eliana Merle: Hey guys, thanks for taking the question. Just on the ONPATTRO ADCOM, I guess just from the interactions and feedback from the FDA so far, do you get the sense that this ADCOM is more specific to the APOLLO-B data, such as being at 12 months, or do you think it sort of is more broadly about the ATTR landscape in cardiomyopathy and the clinical significance in different subgroups? I mean, I guess like in other words, how much do you think the ADCOM would impact AMVUTTRA potential labeling discussion versus this being more of an APOLLO-B specific related discussion at the ADCOM? Thanks.

Tolga Tanguler: Thanks Ellie for your question. Again, as we’ve said at the beginning, we don’t have any particular feedback from the agency on the specifics of what the ADCOM will be or the questions there. And we’ll certainly look forward to hearing more from the agency. We’re committed to supporting their review in any way we can. I do expect that the ADCOM is going to be focused on the APOLLO-B data however. That’s the sNDA that we filed and that would be the subject of the review. Those would be the data that we’d be sharing and talking about in the context of that — the review and the advisory committee as well. But again, we’ll look forward to seeing more from the agency when they get back to us with details.

Yvonne Greenstreet: Yes, and again, I think just to underscore that we believe the APOLLO-B data actually, you know has demonstrated the hypothesis that RNAi therapeutics can have a meaningful impact on patients with TTR amyloidosis with cardiomyopathy. So we shall stop there. Thank you everybody for joining the call. We’re really happy with the progress that we’ve made in the fourth quarter and the full year 2022. We’ve had strong commercial results. We’ve continued to advance our diverse pipeline of programs and developments, and we’ve also got a number of exciting catalysts on deck in 2023. So we look forward to updating you along the way as we continue to deliver on these goals. So thank you everybody, and have a great day.

Operator: Goodbye.