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FDA Drug and Biologic Approvals for Neurology: 2017 Midyear Review

Seven new drugs were approved for treatment of neurological disorders, including Parkinson disease, multiple sclerosis, and amyotrophic lateral sclerosis.

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The FDA has released a list of drug and biologic approvals for 2017 Midyear. Seven new drugs were approved for treatment of neurological disorders, including Parkinson disease, multiple sclerosis, and amyotrophic lateral sclerosis.

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Drug class: Corticosteroid

Defiazacort is a corticosteroid approved for Duchenne muscular dystrophy (DMD) in patients aged 5 years and older.[1] (See also: Duchenne and Becker muscular dystrophy.)

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Drug class: Inhibitor MAO-B and dopamine uptake

Safinamide is approved as an adjunctive treatment to carbidopa/levodopa. It is used for “off” periods in Parkinson disease.[2] (See also: Parkinson Disease Information Page.)

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Drug class: CD-20 monoclonal antibody

Ocrelizumab is approved for relapsing and primary progressive multiple sclerosis, and the first FDA approved drug for the primary progressive form of MS.[3] (See also: Multiple Sclerosis.)

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Drug class: CD-20 monoclonal antibody

Deutetrabenazine is approved for the treatment of chorea associated with Huntington disease.[4] (See also: Huntington Disease.)

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Drug class: VMAT2 inhibitor

Vabenazine is approved for adults with tardive dyskinesia.[5] (See also: Tardive Dyskinesia: A Review of the Literature.)

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Drug class: TPP-1 enzyme replacement therapy

Certiponase is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.[6] (See also: Neuronal ceroid lipofuscinosis [2].)

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Drug class: Pyrazolone free-radical scavenger

Edaravone is approved for amyotropic lateral sclerosis (ALS).[7] (See also: Amyotrophic Lateral Sclerosis.)

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References

1. EmflazaTM PI. Marathon Pharmaceuticals, LLC: Northbrook; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf.

2. Xadago® PI. US WorldMeds: Louisville, KY; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145lbl.pdf.

3. Ocrevus PI. Genentech USA: San Franscisco, CA; 2017. https://www.gene.com/download/pdf/ocrevus_prescribing.pdf.

4. AustedoTM PI. Teva Pharmaceuticals USA, Inc: North Wales, PA; 2017. https://www.austedo.com/pi.

5. IngrezzaTM PI. Neurocrine Biosciences, Inc: San Diego, CA; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf.

6. BrineuraTM PI. BioMarin Pharmaceutical Inc: Novato, CA; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761052lbl.pdf.

7. RadicavaTM PI. MT Pharma America, Inc: Jersey City, NJ; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf.

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