The Latest 10 Novel FDA Drug Approvals

September 29, 2017

What you need to know about the latest new medications.

 

The FDA is having a busy 2017. In 2016, they approved only 22 novel drugs. It’s only the end of September and they’ve already approved 34.

From the first new drug to treat ALS in over two decades to a new Parkinson’s treatment to several new cancer drugs, this year has seen an explosion in both orphan and nonorphan drugs. With the recent promise to start clearing all new orphan drug applications in 90 days, 2017 could still see a glut of new drugs.

We’ve already brought you the last five newly approved drugs, and all the rest before that. Here is what you need to know about the 10 newest drugs. The most recently approved drugs overwhelmingly have been new cancer treatments, but several other indications have gained attention as well.

Up next: Nerlynx

 

Nerlynx (neratinib maleate), Puma Biotechnology

Indications: The extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

Dosage: Recommended dose is 240 mg (6 tablets) given orally once daily with food, continuously for one year. Dose interruptions and/or dose reductions are recommended based on individual safety and tolerability. Reduce starting dose to 80 mg in patients with severe hepatic impairment. Initiate loperamide with the first dose of Nerlynx and continue during first 2 cycles (56 days) of treatment. Instruct patients to maintain 1-2 bowel movements per day and on how to use antidiarrheal treatment regimens.

Contraindications: None.

Read the full prescribing information here

 

Vosevi (sofosbuvir, velpatasvir, and voxilaprevir), Gilead Sciences

Indications: Adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor or genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

Dosage: One tablet (400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir) taken orally once daily with food.

Contraindications: Coadministration with rifampin.

Read the full prescribing information here

 

 

Idhifa (enasidenib), Celgene Corporation and Agios Pharmaceuticals

Indications: Adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

Dosage: 100 mg orally once daily until disease progression or unacceptable toxicity.

Contraindications: None.

Read the full prescribing information here

 

 

Mavyret (glecaprevir and pibrentasvir), AbbVie

Indications: The treatment of patients with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). Also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

Dosage: Three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken orally once daily with food.

Contraindications: Patients with severe hepatic impairment (Child-Pugh C), coadministration with atazanavir and rifampin.

Read the full prescribing information here

 

 

Besponsa (inotuzumab ozogamicin), Pfizer

Indications: Adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Dosage: For injection: 0.9 mg lyophilized powder in a single-dose vial for reconstitution and further dilution. Dosing regimen cycles as follows:

Contraindications: None.

Read the full prescribing information here

 

 

Vabomere (meropenem and vaborbactam), The Medicines Company

Inidciations: Patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria.

Dosage: 4 grams (meropenem 2 grams and vaborbactam 2 grams) every 8 hours by intravenous infusion over 3 hours for up to 14 days. Dosing schedule as follows:

Contraindications: Known hypersensitivity to the components of Vabomere (meropenem and vaborbactam) or anaphylactic reactions to beta-lactams.

Read the full prescribing information here

 

 

Benznidazole, Chemo Group

Indications: Patients 2 to 12 years of age for treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi.

Dosage: Daily dose is 5 mg/kg to 8 mg/kg orally administered in two divided doses separated by approximately 12 hours for a duration of 60 days

Contraindications: History of hypersensitivity reaction to benznidazole or other nitroimidazole derivatives, disulfiram usage within the last two weeks, or alcoholic beverage consumption during and for at least three days after therapy.

Read the full prescribing information here

 

 

Aliqopa (copanlisib), Bayer

Indications: adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Dosage: 60 mg administered as a 1-hour intravenous infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (three weeks on and one week off). Modify dosage for toxicity.

Contraindications: None.

Read the full prescribing information here

 

 

 

Solosec (secnidazole), Symbiomix

Indications: Bacterial vaginosis in adult women.

Dosage: A single 2-gram packet of granules once orally, without regard to the timing of meals. Consume granules in applesauce, yogurt, or pudding, and consume within 30 minutes without chewing the granules.

Contraindications: History of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.

Read the full prescribing information here

 

 

Verzenio (abemaciclib), Eli Lilly

Indications: In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

As a monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

Dosage: Recommended starting dose in combination with fulvestrant: 150 mg twice daily. Recommended starting dose as monotherapy: 200 mg twice daily. Dosing interruption and/or dose reductions may be required based on individual safety and tolerability.

Contraindications: None.

Read the full prescribing information here