What you need to know about the FDA’s most recent novel drug approvals.
Last year, the FDA approved largest number of generic approvals ever in a single year and saw the largest number of New Molecular Entities (NMEs) approved since 1996 (46).
That pace hasn’t slowed in 2018. As of this writing, the FDA has already approved 43 NMEs, putting it well above even last year’s blistering pace. This year’s approvals are wide-ranging, from new cancer medications to cannabis-based products to the first new pain management medication for endometriosis in a decade to the first treatment for smallpox.
Here’s what you need to know about all of the NMEs since June, the last time we covered the FDA’s output.
Moxidectin (Medicines Development for Global Health)
Indications: The treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older.
Dosage: 8 mg (four 2 mg tablets) as a single oral dose, with or without food.
Epidiolex (cannabidiol, GW Pharmaceuticals)
Indications: The treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older
Dosage: Starting dosage is 2.5 mg/kg taken twice daily (5 mg/kg/day). After one week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day).
Contraindications: Hypersensitivity to cannabidiol or any of the ingredients in Epidiolex.
Zemdri (plazomicin, Achaogen)
Indications: The treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis.
Dosage: 15 mg/kg every 24 hours by intravenous (IV) infusion over 30 minutes to patients 18 years of age or older with creatinine clearance greater than or equal to 90 mL/min.
Contraindications: Patients with known hypersensitivity to any aminoglycoside.
Mektovi (binimetinib, Array BioPharma) and Braftovi (encorafenib)
Indications: In combination, the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
Dosage: 45 mg binimetinib orally twice daily in combination with 450 mg encorafenib orally once daily.
TPOXX (tecovirimat, SIGA Technologies)
Indications: The treatment of human smallpox disease in adults and pediatric patients weighing at least 13 kg.
Dosage: Adults: 600 mg twice daily for 14 days
Tibsovo (ivosidenib tablets, Agios)
Indications: The treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
Dosage: 500 mg orally once daily with or without food until disease progression or unacceptable toxicity.
Krintafel (tafenoquine, GSK)
Indications: The radical cure (prevention of relapse) of Plasmodium vivax malaria in patients 16 years and older receiving appropriate antimalarial therapy for acute P. vivax infection.
Dosage: Single dose of 300 mg administered as two 150-mg Krintafel tablets taken together.
Contraindications: G6PD deficiency or unknown G6PD status. Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown. Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of Krintafel.
Orilissa (elagolix, AbbVie)
Indications: The management of moderate to severe pain associated with endometriosis.
Dosage: 150 mg once daily for up to 24 months or 200 mg twice daily for up to 6 months for patients with little no hepatic impairment, 150 mg once daily for up to 6 months for patients with moderate hepatic impairment.
Contraindications: Pregnancy, known osteoporosis, severe hepatic impairment, strong organic anion transporting polypeptide (OATP) 1B1 inhibitors.
Omegaven (fish oil triglycerides, Fresenius Kabi)
Indications: A source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
Dosage: The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day.
Contraindications: Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients. Severe hemorrhagic disorders. Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides greater than 1,000 mg/dL.
Mulpleta (lusutrombopag tablets, Shionogi)
Indications: The treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Dosage: 3 mg orally once daily with or without food for 7 days.
Poteligeo (mogamulizumab-kpkc, Kyowa Kirin)
Indications: The treatment of adult patients with relapsed or refractory mycosis fungoides or SÃ©zary syndrome after at least one prior systemic therapy.
Dosage: 1 mg/kg as an intravenous infusion over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle.
Onpattro (patisiran, Alnylam Pharmaceuticals)
Indications: The treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Dosage: For patients weighing less than 100 kg, the recommended dosage is 0.3 mg/kg every 3 weeks by intravenous infusion. For patients weighing 100 kg or more, the recommended dosage is 30 mg.
Annovera (segesterone acetate and ethinyl estradiol vaginal system, TherapeuticsMD)
Indication: Prevent pregnancy in females of reproductive potential.
Dosage: Must remain in place continuously for 21 days followed by a 1-week vaginal system-free interval.
Contraindications: See label for the full list, including a boxed warning.
Galafold (migalastat, Amicus Therapeutics)
Indications: The treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.
Dosage: 123 mg orally once every other day at the same time of day.
Diacomit (stiripentol, Biocodex)
Indications: The treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.
Dosage: 50 mg/kg/day, administered by mouth in 2 or 3 divided doses.
Oxervate (cenegermin-bkbj, DompÃ©)
Indications: The treatment of neurotrophic keratitis.
Dosage: One drop of Oxervate in the affected eye(s), 6 times per day at 2-hour intervals, for eight weeks.
Takhzyro (lanadelumab-flyo, Shire)
Indications: Prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older
Dosage: 300 mg every 2 weeks. Dosing every 4 weeks may be considered in some patients.
Xerava (eravacycline, Tetraphase pharmaceuticals)
Indications: The treatment of complicated intra-abdominal infections in patients 18 years of age and older.
Dosage: 1 mg/kg by intravenous infusion over approximately 60 minutes every 12 hours for a total duration of 4 to 14 days.
Contraindications: Known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients in Xerava.
Pifeltro (doravirine, Merck)
Indications: In combination with other antiretroviral agents, the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history.
Dosage: One tablet taken orally once daily with or without food. Dosage adjustment with rifabutin: One tablet taken twice daily (approximately 12 hours apart).
Contraindications: Co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers.
Lumoxiti (moxetumomab pasudotox-tdfk, AstraZeneca)
Indications: The treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
Dosage: 0.04 mg/kg as an intravenous infusion over 30 minutes on Days 1, 3, and 5 of each 28-day cycle.
AJOVY (fremanezumab-vfrm, Teva)
Indications: The preventive treatment of migraine in adults.
Dosage: 225 mg monthly, or 675 mg every 3 months (quarterly)
Contraindications: Patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.
Copiktra (duvelisib, Verastem)
Indications: The treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies, or relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.
Dosage: 25 mg orally, twice daily.
Emgality (galcanezumab-gnlm, Lilly)
Indications: The preventive treatment of migraine in adults.
Dosage: 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg.
Contraindications: Patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Vizimpro (dacomitinib, Pfizer)
Indications: The first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
Dosage: 45 mg orally once daily.
Libtayo (cemiplimab-rwlc, Regeneron)
Indications: The treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Dosage: 350 mg as an intravenous infusion over 30 minutes every 3 weeks.
Seysara (sarecycline, Paratek)
Indications: To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Dosage: 60 mg for patients who weigh 33-54 kg, 100 mg for patients who weigh 55-84 kg, 150 mg for patients who weigh 85-136 kg.
Contraindications: Hypersensitivity to any of the tetracyclines.
Nuzyra (omadacycline, Paratek)
Indications: The treatment of adult patients with community-acquired bacterial pneumonia (CABP) or acute bacterial skin and skin structure infections (ABSSSI).
Dosage: For injection: 100 mg of omadacycline, Tablets: 150 mg omadacycline.
Contraindications: Known hypersensitivity to omadacycline, tetracycline-class antibacterial drugs or any of the excipients in NUZYRA.