Daxxify FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 15, 2023.
FDA Approved: Yes (First approved September 7, 2022)
Brand name: Daxxify
Generic name: daxibotulinumtoxinA-lanm
Dosage form: Lyophilized Powder for Injection
Company: Revance Therapeutics, Inc.
Treatment for: Glabellar Lines, Cervical Dystonia
Daxxify (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular blocking agent for the temporary improvement of glabellar (frown) lines and the treatment of cervical dystonia.
- Daxxify is indicated for:
- temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
- the treatment of cervical dystonia in adult patients. - Glabellar lines are vertical lines caused by small muscles between the eyebrows and in the forehead, an area called the glabella. Cervical dystonia is a chronic disease in which the neck muscles contract involuntarily, causing abnormal movements, pain and awkward posture of the head and neck.
- Daxxify is a botulinum toxin product that blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine.
- Daxxify works to improve glabellar lines by temporarily relaxing the facial muscles that cause the lines, thereby reducing their appearance.
- Daxxify works to treat cervical dystonia by blocking the communication between the nerve and the muscle, thereby relaxing the muscle, which alleviates abnormal involuntary movements and postures. - Daxxify is a long-acting neuromodulator stabilized with Peptide Exchange Technology™ (PXT) which makes it last longer compared to conventional neuromodulators.
- Daxxify is administered by intramuscular injection.
- The Daxxify product label carries a boxed warning for the distant spread of botulinum toxin from the injection site, which may cause swallowing and breathing difficulties that can be life threatening.
- Common adverse reactions in patients receiving treatment for glabellar lines include headache, eyelid ptosis and facial paresis.
Common adverse reactions in patients receiving treatment for cervical dystonia include headache, injection site pain, injection site erythema, muscular weakness, and upper respiratory tract infection.
Development timeline for Daxxify
Further information
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