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Similar to the past few years, 2021 will be a major year for advances in the treatment of neurological diseases
.
From sleep disorders to migraines to neuromuscular diseases, the FDA has approved many new treatments to address unmet needs in a range of diseases, including landmark decisions such as Alzheimer's disease
.
This article summarizes some of the new drug therapies approved by the FDA in 2021 for your reference
.
If there are any omissions, readers are welcome to leave a message to inform ~ Yimaitong compiles and organizes, please do not reprint without authorization
.
1.
FDA approves onabotulinumtoxinA for the treatment of children's NDO Detrusor hyperactivity (NDO)
.
In a randomized, double-blind, phase 3 study (NCT01852045) involving more than 100 patients, and a long-term extension study, the use of botulinum toxin a in the treatment of children with NDO was evaluated
.
Studies have shown that in the 6th week, administration of botulinum toxin a into the detrusor reduces the onset of daytime urinary incontinence, reduces the maximum bladder pressure, and increases the bladder capacity
.
2.
FDA approves ponesimod for the treatment of relapsing multiple sclerosis FDA has approved ponesimod (Ponvory; Janssen Pharmaceutical), an oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, functional Inhibit S1P activity and reduce circulating lymphocytes.
It is used to treat adult relapsing multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
.
3.
FDA approves mirabegron sustained-release tablets, oral suspension approved for the treatment of NDO FDA has approved Mirabegron sustained-release tablets (Myrbetriq) and Mirabegron oral suspension (Myrbetriq granules) developed by Astellas Pharma , Used to treat NDO in children 3 years and older
.
Astellas is also suitable for the treatment of overactive bladder in adult patients.
It was initially approved in 2012, but the recommended dose of adult sustained-release oral suspension has not been determined
.
In an open-label single-group assignment study of 86 patients aged 3-17 years (titled CROCODILE (NCT02751931)), the efficacy of two preparations in the treatment of children's NDO was determined
.
The study was evaluated in a group of children aged 3 to under 12 (n=55) and a group of adolescents aged 12 to under 18 (n=35)
.
At 24 weeks, an improvement in the patient's maximum bladder capacity (MCC) was observed, which was significantly improved in both treatment groups
.
In addition, after 24 weeks of treatment, secondary outcome indicators such as the number of detrusor contractions (>15cm H20), the volume of urine until the first detrusor contraction (>15cm H20), and the number of daily leaks all showed improvement
.
4.
FDA approves rimegepant for the preventive treatment of migraine FDA has approved 75mg rimegepant (Nurtec ODT; Biohaven) for the preventive treatment of migraine, and has added the indications previously used for the acute treatment of headache diseases, which marks it Become the first oral calcitonin gene-related peptide (CGRP) antagonist approved for prevention and the first CGRP antagonist approved for acute and preventive treatment
.
Click to review for more details ☟☟☟Rimegepant's indications have been expanded and the FDA approved it for the prevention of adult migraine 5.
FDA approves aducanumab for the treatment of Alzheimer’s disease FDA has approved Biogen’s research anti-amyloid protein The disease modifier aducanumab is used to treat Alzheimer's disease.
This is the first new therapy approved for the treatment of Alzheimer's disease since 2003
.
The trade name of the drug is Aduhelm
.
The therapy was approved under the accelerated approval pathway, which will require Biogen to conduct post-approval Phase 4 studies to confirm the benefits of the drug
.
Click to review, more detailed content ☟☟☟Heavy! New hope for Alzheimer’s disease-the world’s first drug to delay the progression of AD was approved 6.
FDA approves Xywav for the treatment of idiopathic narcolepsy Jazz Pharmaceuticals announced that the FDA has approved JZP-258 (listed as Xywav), For the treatment of idiopathic narcolepsy, this is the first therapeutic drug approved for this indication
.
Idiopathic narcolepsy is a debilitating neurological sleep disorder characterized by chronic excessive daytime sleepiness (EDS)
.
JZP-258 was initially approved in July 2020 for the treatment of cataplexy or EDS in narcolepsy patients 7 years of age or older
.
The approval is based on a phase 3 double-blind, placebo-controlled, randomized-withdrawal, multi-center study.
Compared with placebo, the drug's number of episodes per week and Epworth Sleepiness Scale scores There is a statistically significant difference (P<0.
0001)
.
7.
FDA approves brivaracetam for the treatment of partial seizures in children.
The FDA has approved brivaracetam (Briviact; UCB Pharma) CV tablets and oral solution for extended indications, which is a drug for the treatment of children with partial seizures
.
This indication also includes intravenous (IV) administration formulations for situations where oral administration is temporarily impossible
.
This is the first IV drug used for this indication in the past 7 years
.
Brivaracetam is a derivative of the third-generation antiepileptic drug Piracetam and a 4-n-propyl analogue of Levetiracetam (Keppra; UCB Pharma).
It has now been approved as a monotherapy or adjuvant therapy and is available in tablets Agent, oral solution and IV administration
.
8.
FDA approves INP104 nasal spray for acute migraine treatment FDA has approved INP104 nasal spray for acute treatment of migraine in adults
.
This is the first and only approved therapy using Precision Olfactory Delivery (POD) technology, a new delivery system specifically for the upper nasal cavity
.
Intranasal administration of INP104 can optimize dihydroergotamine mesylate (DHE) for rapid migraine relief
.
Compared with other nasal-administered, FDA-approved products, the drug delivery system is also designed to deliver lower doses of DHE, thereby reducing the adverse reactions normally associated with the delivery of DHE to the lower nasal cavity
.
9.
FDA approves atogepant for the prevention of paroxysmal migraine FDA has approved atogepant (Qulipta) for the preventive treatment of adult patients with paroxysmal migraine, making it the first oral calcitonin gene-related peptide (CGRP) receptor antagonist Agent
.
Together with rimegepant (Nurtec ODT; Biohaven), it became the second FDA-approved overall member of the gepant category
.
10.
FDA approves the first oral solution of topiramate for the treatment of epilepsy and migraine FDA has approved Azurity Pharmaceuticals' 25mg/ml oral formulation of topiramate to be marketed as Eprontia for the treatment of various diseases such as epilepsy and migraine, making it the No.
One and only liquid formulation that received the green light
.
Eprontia is currently used as a single agent for oral treatment of partial seizures or primary generalized tonic-clonic seizures in patients aged 2 years and older, as an adjuvant therapy for partial seizures, primary generalized tonic-clonic seizures of the same age group Seizures or seizures related to Lennox-Gastaut syndrome, and preventive treatment of migraine in patients 12 years and older
.
11.
FDA approves efgartigimod for the treatment of myasthenia gravis FDA has approved efgartigimod (Vyvgart, argenx) for the treatment of adult patients with generalized myasthenia gravis (gMG) who have tested positive for anti-acetylcholine receptor (AChR) antibodies
.
Efgartigimod is a pioneering targeted therapy drug, and its approval provides a new treatment option for patients with rare diseases
.
In the Phase 3, randomized, placebo-controlled ADAPT trial, the trial enrolled 187 gMG adult patients
.
Under the background of a stable dose of at least one MG drug, all patients have myasthenia gravis-activity of daily living score of at least 5 points
.
Within 26 weeks, 84 patients were randomly assigned to receive efgartigimod 10 mg/kg and 83 patients received matching placebo
.
Both treatments are 4 infusions per cycle and 1 infusion per week
.
Efgartigimod treatment can reduce the disease burden of gMG patients and improve their physical strength and quality of life
.
In addition, these benefits are observed at an early stage and are repeatable and long-lasting
.
Click to review, more detailed content ☟☟☟Heavy! The world's first FcRn antagonist was approved by the FDA.
References: 1.
FDA official website.
2.
NeurologyLive® Year in Review 2021: FDA Stories.
.
From sleep disorders to migraines to neuromuscular diseases, the FDA has approved many new treatments to address unmet needs in a range of diseases, including landmark decisions such as Alzheimer's disease
.
This article summarizes some of the new drug therapies approved by the FDA in 2021 for your reference
.
If there are any omissions, readers are welcome to leave a message to inform ~ Yimaitong compiles and organizes, please do not reprint without authorization
.
1.
FDA approves onabotulinumtoxinA for the treatment of children's NDO Detrusor hyperactivity (NDO)
.
In a randomized, double-blind, phase 3 study (NCT01852045) involving more than 100 patients, and a long-term extension study, the use of botulinum toxin a in the treatment of children with NDO was evaluated
.
Studies have shown that in the 6th week, administration of botulinum toxin a into the detrusor reduces the onset of daytime urinary incontinence, reduces the maximum bladder pressure, and increases the bladder capacity
.
2.
FDA approves ponesimod for the treatment of relapsing multiple sclerosis FDA has approved ponesimod (Ponvory; Janssen Pharmaceutical), an oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, functional Inhibit S1P activity and reduce circulating lymphocytes.
It is used to treat adult relapsing multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
.
3.
FDA approves mirabegron sustained-release tablets, oral suspension approved for the treatment of NDO FDA has approved Mirabegron sustained-release tablets (Myrbetriq) and Mirabegron oral suspension (Myrbetriq granules) developed by Astellas Pharma , Used to treat NDO in children 3 years and older
.
Astellas is also suitable for the treatment of overactive bladder in adult patients.
It was initially approved in 2012, but the recommended dose of adult sustained-release oral suspension has not been determined
.
In an open-label single-group assignment study of 86 patients aged 3-17 years (titled CROCODILE (NCT02751931)), the efficacy of two preparations in the treatment of children's NDO was determined
.
The study was evaluated in a group of children aged 3 to under 12 (n=55) and a group of adolescents aged 12 to under 18 (n=35)
.
At 24 weeks, an improvement in the patient's maximum bladder capacity (MCC) was observed, which was significantly improved in both treatment groups
.
In addition, after 24 weeks of treatment, secondary outcome indicators such as the number of detrusor contractions (>15cm H20), the volume of urine until the first detrusor contraction (>15cm H20), and the number of daily leaks all showed improvement
.
4.
FDA approves rimegepant for the preventive treatment of migraine FDA has approved 75mg rimegepant (Nurtec ODT; Biohaven) for the preventive treatment of migraine, and has added the indications previously used for the acute treatment of headache diseases, which marks it Become the first oral calcitonin gene-related peptide (CGRP) antagonist approved for prevention and the first CGRP antagonist approved for acute and preventive treatment
.
Click to review for more details ☟☟☟Rimegepant's indications have been expanded and the FDA approved it for the prevention of adult migraine 5.
FDA approves aducanumab for the treatment of Alzheimer’s disease FDA has approved Biogen’s research anti-amyloid protein The disease modifier aducanumab is used to treat Alzheimer's disease.
This is the first new therapy approved for the treatment of Alzheimer's disease since 2003
.
The trade name of the drug is Aduhelm
.
The therapy was approved under the accelerated approval pathway, which will require Biogen to conduct post-approval Phase 4 studies to confirm the benefits of the drug
.
Click to review, more detailed content ☟☟☟Heavy! New hope for Alzheimer’s disease-the world’s first drug to delay the progression of AD was approved 6.
FDA approves Xywav for the treatment of idiopathic narcolepsy Jazz Pharmaceuticals announced that the FDA has approved JZP-258 (listed as Xywav), For the treatment of idiopathic narcolepsy, this is the first therapeutic drug approved for this indication
.
Idiopathic narcolepsy is a debilitating neurological sleep disorder characterized by chronic excessive daytime sleepiness (EDS)
.
JZP-258 was initially approved in July 2020 for the treatment of cataplexy or EDS in narcolepsy patients 7 years of age or older
.
The approval is based on a phase 3 double-blind, placebo-controlled, randomized-withdrawal, multi-center study.
Compared with placebo, the drug's number of episodes per week and Epworth Sleepiness Scale scores There is a statistically significant difference (P<0.
0001)
.
7.
FDA approves brivaracetam for the treatment of partial seizures in children.
The FDA has approved brivaracetam (Briviact; UCB Pharma) CV tablets and oral solution for extended indications, which is a drug for the treatment of children with partial seizures
.
This indication also includes intravenous (IV) administration formulations for situations where oral administration is temporarily impossible
.
This is the first IV drug used for this indication in the past 7 years
.
Brivaracetam is a derivative of the third-generation antiepileptic drug Piracetam and a 4-n-propyl analogue of Levetiracetam (Keppra; UCB Pharma).
It has now been approved as a monotherapy or adjuvant therapy and is available in tablets Agent, oral solution and IV administration
.
8.
FDA approves INP104 nasal spray for acute migraine treatment FDA has approved INP104 nasal spray for acute treatment of migraine in adults
.
This is the first and only approved therapy using Precision Olfactory Delivery (POD) technology, a new delivery system specifically for the upper nasal cavity
.
Intranasal administration of INP104 can optimize dihydroergotamine mesylate (DHE) for rapid migraine relief
.
Compared with other nasal-administered, FDA-approved products, the drug delivery system is also designed to deliver lower doses of DHE, thereby reducing the adverse reactions normally associated with the delivery of DHE to the lower nasal cavity
.
9.
FDA approves atogepant for the prevention of paroxysmal migraine FDA has approved atogepant (Qulipta) for the preventive treatment of adult patients with paroxysmal migraine, making it the first oral calcitonin gene-related peptide (CGRP) receptor antagonist Agent
.
Together with rimegepant (Nurtec ODT; Biohaven), it became the second FDA-approved overall member of the gepant category
.
10.
FDA approves the first oral solution of topiramate for the treatment of epilepsy and migraine FDA has approved Azurity Pharmaceuticals' 25mg/ml oral formulation of topiramate to be marketed as Eprontia for the treatment of various diseases such as epilepsy and migraine, making it the No.
One and only liquid formulation that received the green light
.
Eprontia is currently used as a single agent for oral treatment of partial seizures or primary generalized tonic-clonic seizures in patients aged 2 years and older, as an adjuvant therapy for partial seizures, primary generalized tonic-clonic seizures of the same age group Seizures or seizures related to Lennox-Gastaut syndrome, and preventive treatment of migraine in patients 12 years and older
.
11.
FDA approves efgartigimod for the treatment of myasthenia gravis FDA has approved efgartigimod (Vyvgart, argenx) for the treatment of adult patients with generalized myasthenia gravis (gMG) who have tested positive for anti-acetylcholine receptor (AChR) antibodies
.
Efgartigimod is a pioneering targeted therapy drug, and its approval provides a new treatment option for patients with rare diseases
.
In the Phase 3, randomized, placebo-controlled ADAPT trial, the trial enrolled 187 gMG adult patients
.
Under the background of a stable dose of at least one MG drug, all patients have myasthenia gravis-activity of daily living score of at least 5 points
.
Within 26 weeks, 84 patients were randomly assigned to receive efgartigimod 10 mg/kg and 83 patients received matching placebo
.
Both treatments are 4 infusions per cycle and 1 infusion per week
.
Efgartigimod treatment can reduce the disease burden of gMG patients and improve their physical strength and quality of life
.
In addition, these benefits are observed at an early stage and are repeatable and long-lasting
.
Click to review, more detailed content ☟☟☟Heavy! The world's first FcRn antagonist was approved by the FDA.
References: 1.
FDA official website.
2.
NeurologyLive® Year in Review 2021: FDA Stories.
