RALEIGH, N.C. – May 13, 2019 – Merz Americas announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin(incobotulinumtoxinA), broadening its indication to be a first-line treatment of blepharospasm (involuntary blinking) in adult patients.
“Merz is proud to offer a first-line treatment option for blepharospasm, a devastating condition that has no cure and affects up to 50,000 patients in the U.S.,”1 said Kevin O’Brien, Vice President and U.S. Head of Neurosciences, Merz. “This milestone, along with the July 2018 approval of Xeomin for the treatment of chronic sialorrhea (drooling) in adults, reinforces our commitment to providing comprehensive care for patients living with movement disorders.”
Blepharospasm causes muscles around the eyes to contract involuntarily. Patients suffering from blepharospasm can experience symptoms including excessive blinking, light sensitivity, dry eyes, eye irritation and watering eyes, and symptoms may worsen over time.1,2
The approval is based on a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial in a total of 61 treatment-naïve patients who had a diagnosis of blepharospasm with a baseline Jankovic Rating Scale (JRS) Severity subscore ≥2. JRS is the most commonly used clinical scale to measure severity and frequency of blepharospasm.Patients were defined as treatment-naïve if at least 12 months had passed since their last toxin treatment.
The primary efficacy endpoint was the change from baseline in JRS Severity subscore determined at week 6 after the Xeomin injection. The 50 unit treatment group demonstrated statistically significant improvement compared to placebo, with a difference of -1.2 (p=0.0004). The safety findings were similar to previous studies and in line with the known safety profile of Xeomin.
Xeomin was first approved by the FDA in 2010 for the treatment of blepharospasm (previously treated with onabotulinumtoxinA) and cervical dystonia in adult patients and later in 2015 for upper limb spasticity in adult patients. Most recently, Xeomin was approved by the FDA in July 2018 to treat chronic sialorrhea (excessive drooling) in adult patients.
1127-74-8,1,2,3,4-Tetrahydro-benzo[b]azepin-5-one
Read More4038-14-6,(3,4-dimethoxyphenyl)-phenylmethanone
Read More2338-76-3,2-[3-(trifluoromethyl)phenyl]acetonitrile
Read More351-35-9,2-[3-(trifluoromethyl)phenyl]acetic acid
Read More2997-92-4,2,2'-Azobis(2-methylpropionamidine) dihydrochloride
Read More95585-78-7,L-Phenylalanine, 1-methylethyl ester, hydrochloride
Read More20324-87-2,Disodium 7,7'-(carbonyldiimino)bis(4-hydroxynaphthalene-2-sulphonate)
Read More182498-32-4,1-(2-bromophenyl)-3-(2-hydroxy-4-nitrophenyl)urea
Read More1101854-58-3,(4-nitrophenyl) 4-[bis(1,3-benzodioxol-5-yl)-hydroxymethyl]piperidine-1-carboxylate
Read More170565-89-6,N,N-dimethyl-2-oxo-1,3-dihydroindole-5-sulfonamide
Read More1460-59-9,5,6,11,12-tetrahydrodibenzo[1,2-b:1',2'-g][8]annulene
Read More284035-33-2,2-chloro-6-[(2R)-2-hydroxy-3-[(2-methyl-1-naphthalen-2-ylpropan-2-yl)amino]propoxy]benzonitrile
Read More440662-09-9,N-(2,3-dihydrobenzo[b][1,4]dioxin-6-yl)-2-methyl-1-oxo-1,2-dihydroisoquinoline-4-carboxamide
Read More932986-18-0,N-[2-[2-(4-chlorophenyl)-1,3-thiazol-4-yl]ethyl]butanamide
Read More1234015-52-1,5-(5-(2-(3-aminopropoxy)-6-methoxyphenyl)-1H-pyrazol-3-ylamino)pyrazine-2-carbonitrile
Read More1651890-44-6,3'-Methyl-3''-[(1E)-2-phenylethenyl]-3,2':5',2'':5'',3'''-quaterpyridine
Read More1469924-27-3,3-[4'-(Dimethylamino)-3-biphenylyl]-1,1-dimethylure
Read More3897-94-7,8-Methoxy-N,N-dipropyl-1,2,3,4-tetrahydro-2-naphthalenamine
Read More1202759-32-7,4-{4-[(4-{[3-(Acryloylamino)phenyl]amino}-5-fluoro-2-pyrimidinyl) amino]phenoxy}-N-methyl-2-pyridinecarboxamide
Read More71145-03-4,1,4-Dihydro-2,6-dimethyl-3-nitro-4-(2-trifluoromethylphenyl)-pyridine-5-carboxylic acid methyl ester
Read More500579-04-4,2-[[3-[[2-(dimethylamino)phenyl]methyl]-2-pyridin-4-yl-1,3-diazinan-1-yl]methyl]-N,N-dimethylaniline
Read More1443437-74-8,N-(4-chlorophenyl)-1-(3-(furan-2-yl)benzoyl)piperidine-3-carboxamide
Read More1125-29-7 1,3,5-Trimethyl-1H-pyrazole-4-carboxylic acid
Read More23362-56-3 [2-(aminocarbonyl)phenyl]acetic acid
Read More103788-65-4 2-(5-Methyl-2-phenyl-1,3-oxazol-4-yl)ethan-1-ol
Read More120503-69-7 2-Amino-6-cyclopropylamino-9H-purine
Read More