It’s been a busy year for the FDA. We’ve shown you the first 9 novel drug approvals this year and we already need a new list. At 19 new drug approvals, the FDA has nearly surpassed its 2016 total of only 22 approvals.
Here is a brief overview of the latest FDA novel drug approvals, in order of when they were approved.
Up next: A treatment for opioid induced constipation
SYMPROIC (naldemedine), Purdue Pharma
Indications: Treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Dosage: 0.2 mg once daily with or without food.
Contraindications: Patients with known or suspected gastrointestinal obstruction or at increased risk of recurrent obstruction. Patients with a history of a hypersensitivity reaction to naldemedine.
DUPIXENT (dupilumab), Sanofi and Regeneron
Indications: The treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Dosage: 300 mg/2 mL solution injection.
Contraindications: Known hypersensitivity to Dupixent or any of its excipients.
OCREVUS (ocrelizumab), Genentech
Indications: A CD20-directed cytolytic antibody indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis.
Dosage: Start dose is 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion and subsequent 600 mg intravenous infusion every 6 months.
Contraindications: Active hepatitis B virus infection, history of life-threatening infusion reaction to OCREVUS.
AUSTEDO (deutetrabenazine), Teva
Indications: A vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease.
Dosage: Starting dose is 6 mg once daily. Titrate up at weekly intervals by 6 mg per day to a tolerated dose that reduces chorea, up to a maximum recommended daily dosage of 48 mg (24 mg twice daily). Administer total daily dosages of 12 mg or above in two divided doses. Take with food.
Contraindications: Suicidal, or untreated/inadequately treated depression; hepatic impairment; or concurrent MAOIs, reserpine, or tetrabenazine.
INGREZZA (valbenazine), Neurocrine
Indications: A vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.
Dosage: Initial dose is 40 mg once daily, after one week, increase the dose to the recommended dose of 80 mg once daily. Can be taken with or without food. The recommended dose for patients with moderate or severe hepatic impairment is 40 mg once daily. Consider dose reduction based on tolerability in known CYP2D6 poor metabolizers.
BRINEURA (cerliponase alfa), BioMarin
Indications: A hydrolytic lysosomal N-terminal tripeptidyl peptidase 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.
Dosage: Injection: Brineura 150 mg/5 mL (30 mg/mL) solution, two single-dose vials per carton co-packaged with Intraventricular Electrolytes Injection 5 mL in a single-dose vial. Brineura is administered to the cerebrospinal fluid by infusion via a surgically implanted reservoir and catheter.
Contraindications: Acute complications related to the intraventricular access device(e.g., leakage, device failure, or device-related infection) or patients with ventriculoperitoneal shunts.
ALUNBRIG (brigatinib), Takeda
Indications: a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib.
Dosage: 90 mg orally once daily for the first 7 days; if tolerated, increase to 180 mg orally once daily.
RYDAPTÂ (midostaurin), Novartis
Indications: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Not indicated as a single-agent induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia. Strong CYP3A4 Inhibitors: Strong CYP3A4 inhibitors may increase (MCL).
Dosage: AML: 50 mg orally twice daily with food. ASM, SM-AHN, and MCL: 100 mg orally twice daily with food.
Contraindications: Hypersensitivity to midostaurin or any of the excipients.
TYMLOS (abaloparatide), Radius
Indications: A human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture.
Dosage: 80 mcg subcutaneously once daily; patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Administer as a subcutaneous injection into periumbilical region of abdomen.
IMFINZI (durvalumab), AstraZeneca
Indications: Imfinzi is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Dosage: Administer 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks. Dilute prior to intravenous infusion.
Bonus: gammaCore, ElectroCore Medical
gammaCore is a class II device under the category of external vagal nerve stimulator for headache, which according to the FDA is a “prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.”
gammaCore is approved to treat pain associated with cluster headaches. It is not indicated for patients with an active implantable medical device; carotid atherosclerosis; cervical vagotomy; clinically significant hypertension, hypotension, bradycardia, or tachycardia; or pediatric patients or pregnant women.