By Leroy Leo
Aug 14 (Reuters) - The U.S. health regulator has
approved expanding the use of Revance Therapeutics' Daxxify
RVNC.O to treat a painful neck muscle condition, intensifying
the anti-wrinkle injection's rivalry with AbbVie's ABBV.N
Botox.
The approval by the Food and Drug Administration helps
Revance enter the $2.5 billion U.S. market for therapeutic
neuromodulator, a method that directly acts on nerves, the
company said on Monday.
Cervical dystonia accounts for about $345 million of that
market. The painful condition involves involuntary contraction
of neck muscles and causes the head to twist to one side.
Revance will move into a preview phase with some doctors and
key opinion leaders (KOLs) initially after the approval, company
executives told Reuters before the decision.
"We'll use that group as our faculty to then train that
broader launch group which will be in 2024," President Dustin
Sjuts said.
Revance said it would share more information on the pricing
when the product is launched commercially.
The company has been trying to attract clients to Daxxify
from its more popular rival with its "Break Up with Botox"
marketing campaign.
The newer anti-wrinkle injection recorded $22.6 million in
sales in the second quarter.
The California-based company is counting on Daxxify's longer
treatment duration to attract more doctors and patients from
Botox.
Most cervical dystonia patients saw the treatment effect
last about 20 weeks and 24 weeks when using different dosages of
Daxxify, a late-stage study showed, compared with three months
for Botox, as per FDA data.
This was similar for Daxxify when it had secured U.S.
approval as an anti-wrinkle injection last year.
(Reporting by Leroy Leo in Bengaluru; Editing by Sriraj
Kalluvila)
((Leroy.Dsouza@thomsonreuters.com ; Twitter: https://twitter.com/LeroyLeo7;))