Amondys 45 — Competitive Intelligence Brief

Amondys 45 (CASIMERSEN) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antisense Oligonucleotide [EPC]. Area: Rare Disease.

marketed Antisense Oligonucleotide [EPC] exon 53 of dystrophin pre-mRNA Rare Disease Oligonucleotide

Target snapshot

Amondys 45 (CASIMERSEN) — Sarepta. Amondys 45 works by binding to specific RNA sequences to prevent the production of a faulty protein that causes Duchenne muscular dystrophy.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Amondys 45 TARGET	CASIMERSEN	Sarepta	marketed	Antisense Oligonucleotide [EPC]	exon 53 of dystrophin pre-mRNA	2021-01-01
Viltepso	VILTOLARSEN	Nippon Shinyaku	marketed		exon 53 of dystrophin pre-mRNA	2020-01-01
Vyondys 53	GOLODIRSEN	Sarepta	marketed	Antisense Oligonucleotide [EPC]	exon 53 of dystrophin pre-mRNA	2019-01-01
Qalsody	TOFERSEN	Biogen Ma	marketed	Antisense Oligonucleotide [EPC]	Superoxide dismutase 1 (SOD1) mRNA	2023-01-01
Exondys 51	ETEPLIRSEN	Sarepta	marketed	Antisense Oligonucleotide [EPC]	exon 51 of dystrophin pre-mRNA	2016-01-01
Kynamro	MIPOMERSEN	Kastle Theraps Llc	marketed	Antisense Oligonucleotide		2013-01-01
PF-07852352 Influenza saRNA 1	pf-07852352-influenza-sarna-1	Pfizer	marketed	antisense oligonucleotide	influenza virus

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antisense Oligonucleotide [EPC] class)

1. Sarepta · 3 drugs in this class
2. Biogen Ma · 1 drug in this class