Revance Therapeutics Inc (RVNC)

[mouton29]

You say,

Rather than having a lasting treatment, the condition treated starts to return in three months or less and you have to live with it for another three months or more.

Evidently you believe that redosing is not permitted for 6 months? Where is this coming from? It’s flat wrong.

From the package insert:

DAXXIFY should be administered no more frequently than every three months.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761127s000lbl.pdf

And later, we have:

In an 84-week open label repeat-dose safety study in glabellar lines, 2691 subjects were treated with 40 U of
DAXXIFY. Of these, 2380 subjects received one treatment with DAXXIFY, 882 received two treatments with
DAXXIFY and 568 subjects received three treatments with DAXXIFY. Adverse reactions were reported in 535
of the 2691 subjects (20%). The adverse reaction profile was similar to that reported in single dose trials.
Injection site reactions were the most common adverse reactions, reported in 9% of subjects [including injection
site pain (4%) , injection site erythema (3%), injection site oedema (3%), injection site bruising (1%), injection
site papule (<1%), injection site pruritus (<1%)], followed by headache (5%), edema (2%), erythema (2%) and
eyelid ptosis in 1% of subjects. The incidence of these adverse reactions did not increase with multiple re-
treatments.
6.2 Immunogenicity
…
Treatment with botulinum toxins may result in the formation of antibodies that may reduce the effectiveness of
subsequent treatments by inactivating biological activity of the toxin.
Among 2786 subjects receiving up to 3 treatments with DAXXIFY in the phase 3 studies, 12 Subjects (0.4%)
had preexisting binding antibodies to daxibotulinumtoxinA-lanm and 75 (3%) had preexisting binding
antibodies to the 35 amino acid peptide excipient RTP004. A total of 20 (0.8%) subjects developed treatment-
emergent binding antibodies to daxibotulinumtoxinA-lanm and 33 (1.2%) subjects developed treatment-
emergent binding antibodies to RTP004. No subjects developed neutralizing antibodies to DAXXIFY. [Emphasis added]

The data discussed above in the package insert is presented in more detail in the peer reviewed articles summarizing results for the Daxi open label trial— redosing took place as early as after 12 weeks.