9 Newly Approved Novel Drugs

March 24, 2017

It's still early in 2017, but the FDA has been approving drugs left and right. Here's what you need to know.

It’s been a busy 2017 for the FDA … already. The agency is well on track to outpace last year’s 22 novel drug approvals.

Here’s a quick overview of the nine novel drugs approved in 2017 along with links to FDA releases and package inserts. The drugs are all listed in order of approval, starting with the earliest. 

Up next: The first novel drug approval of 2017

 

1. Trulance (plecanatide), Synergy Pharmaceuticals

Indication: Chronic idiopathic constipation in adults. It works in the upper GI tract to stimulate secretion of intestinal fluid and help support regular bowel function.

Dosage: 3 mg/d PO.

Contraindications: Drug cannot be used in children under age 6 and in patients with known or suspected mechanical GI obstruction.

Read the FDA statement here

Read the full prescribing information here

 

2. Parsabiv (etelcalcetide), Amgen

Indication: A calcimimetic approved to manage secondary hyperparathyroidism in adults with chronic kidney disease who are on hemodialysis.

Dosage: Recommended starting dose is 5 mg by IV bolus injection three times per week at the end of hemodialysis treatment.

Contraindications: Known hypersensitivity to etelcalcetide or any of its excipients.

Read the report here

Read the full prescribing information here

 

 

3. Emflaza (deflazacort), Marathon Pharmaceuticals

Indication: A corticosteroid approved for treatment of Duchenne muscular dystrophy, the most common form of muscular dystrophy, in patients five years of age or older.

Dosage: Oral dosage approximately 0.9 mg/kg/day once daily; for oral suspension round up to the nearest tenth of a milliliter.

Contraindications: Known hypersensitivity to deflazacort or to any inactive ingredients.

Read our coverage of this drug and troubles with its pricing here

Read the full prescribing information here

 

 

4. Siliq (brodalumab), Valeant Pharmaceuticals

Indications: A human interleukin-17 receptor A (IL-17RA) antagonist used to manage moderate-to-severe plaque psoriasis. It is indicated for adultcandidates for systemic therapy or phototherapy who have failed to respond or who have stopped responding to other systemic therapies.

Dosage: 210 mg by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks.

Contraindications: Crohn’s disease

Read the FDA statement here

Read the full prescribing information here

 

 

5. Xermelo (telotristat ethyl), Lexicon Pharmaceuticals, Inc.

Indications: A tryptophan hydroxylase inhibitor indicated for carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults whose diarrhea is adquately controlled by SSA therapy.

Dosage: 250 mg tid with food.

Contraindications: None

Read the FDA statement here

Read the full prescribing information here

 

 

6. KISQALI (ribociclib), Novartis

Indications: A kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

Dosage: 600 mg orally (three 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.

Contraindications: None

Read the FDA statement here

Read the full prescribing information here

 

 

7. Xadago (safinamide), Newron Pharmaceuticals

Indications: A monoamine oxidase type B (MAO-B) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

Dosage: Initial dosage is 50 mg PO daily. After 2 weeks, may increase dose to 100 mg PO daily , based on individual need and tolerability.

Contraindications: Severe hepatic impairment or hypersensitivity to the active substance or to any of the excipients. Coadministration with other MAOIs; opioids; St John’s wort, or tricyclic, tetracyclic, or triazolopyridine antidepressants; cyclobenzaprine; methylphenidate or amphetamine and their derivatives; Dextromethorphan; or selective norepinephrine reuptake inhibitors.

Read the FDA statement here

Read the full prescribing information here

 

 

8. Bavencio (avelumab), EMD Serono Inc.

Indications: A programmed death ligand-1 (PD-L1) blocking antibody indicated for patients 12 years and older with metastatic Merkel cell carcinoma (MCC). BAVENCIO is under accelerated approval, and continued approval will be contingent on further trials.

Dosage: 10 mg/kg as an IVinfusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. All patients should receive premedication with an antihistamine and acetaminophen prior to the first four infusions of avelumab. 

Contraindications: None

Read the FDA statement here

Read the full prescribing information here

 

9. Zejula (niraparib), Tesaro, Inc.

Indication: A poly(ADP-ribose) polymerase (PARP) inhibitor indicated for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Dosage: 300 mg (three 100 mg capsules) taken orally once daily.

Contraindications: None

Read the full prescribing information here