Although the efficacy data was promising, the safety concerns might give regulators pause.
The FDA once put a clinical hold on inotersen, causing Ionis’s partner on the drug, GlaxoSmithKline (GSK), to edge away from its collaboration on the program. GSK still has an option to snag marketing rights on the drug.
On an investor call, Ionis senior vice president of drug discovery Brett Monia said the safety concerns can be closely watched, are “manageable” and that reactions can be reversed if caught early enough.
Monia said the data suggests the drug may deliver more benefit than risk. The FDA might agree, given the lack of available alternatives for the drug.
On the call, CEO Stanley Crooke said Ionis “assumes” GSK will exercise its option to acquire marketing rights for the drug, but “will be delighted” to commercialize inotersen on its own if GSK isn’t interested.
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