2018 Novel Drug Approvals: The First Five


Signs point to a cooling on the FDA's fiery approval pace of 2017, but 2018 has already seen five novel drug approvals.

Last year was a huge year for novel drug approvals-a 21-year high with 46 approvals-so don’t expect this year to match it. But at the time of writing last year, the FDA had only approved six new drugs, compared to five this year, so it isn’t that much of a drop-off so far.

March 2017, however, was a huge month, seeing seven new approvals within just 15 days, so it remains to be seen if 2018 will be able to keep pace. Generic drug approvals are already falling behind-despite the FDA’s goal to keep its furious pace going-with a dismal 25 approvals in January and 32 in February, compared with 84 and 78 in the final two months of 2017, respectively. According to Regulatory Focus, this slowdown is due to a new rule implemented January 1st designed to limit elemental impurities. Regardless of new rules, however, 2018 is still pacing well ahead of 2016’s abysmal 22 approvals.

Here are the first five novel drug approvals of the year, including two new HIV medications.



LUTATHERA (lutetium Lu 177 dotatate), Advanced Accelerator Applications

Indications: for the reduce treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Dosage: Administer 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses.

Contraindications: None.

Click here to read the full label



Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide), Gilead Sciences

Indications: A complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed.

Dosage: One tablet taken once daily with or without food.

Contraindications: Contraindicated with co-administration of dofetilide and rifampin.

Click here to read the full label


SYMDEKO (tezacaftor/ivacaftor), Vertex Pharmaceuticals

Indications: The treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

Dosage: One tablet (containing tezacaftor 100 mg/ivacaftor 150 mg) in the morning and one tablet (containing ivacaftor 150 mg) in the evening, approximately 12 hours apart. SYMDEKO should be taken with fat-containing food.

Contraindications: None.

Click here to read the full label


Erleada (apalutamide), Janssen

Indications: The treatment of patients with nonmetastatic castration-resistant prostate cancer.

Dosage: 240 mg (four 60 mg tablets) administered orally once daily. Swallow tablets whole. Can be taken with or without food.

Contraindications: Pregnancy.

Click here to read the full label


Trogarzo (ibalizumab-uiyk), Thera Technologies

Indications: The treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

Dosage: Administered intravenously (IV) as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks after dilution in 250 mL of 0.9% sodium chloride injection, USP.

Contraindications: None.

Click here to read the full label


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