10 FDA Approvals to Know from 2017

DECEMBER 27, 2017
Jennifer Barrett, Assistant Editor
Over the past year, several new treatments with a wide range of therapeutic indications were given the green light from the FDA.

With the New Year on our heels, let’s look back on some of the most noteworthy FDA approvals of 2017.

1. AirDuo RespiClick
 
The FDA approved Teva’s fluticasone propionate and salmeterol inhalation powder (AirDuo RespiClick) on January 30, 2017.
 
AirDuo RespiClick, a corticosteroid and long-acting beta2-adrenergic agonist, is indicated for the twice-daily treatment of asthma in patients aged 12 years and older. The drug is delivered via Teva’s RespiClick breath-activated, multi-dose dry powder inhaler.
 
The most common adverse effects reported by trial participants treated with AirDuo RespiClick include nasopharyngitis, headache, cough, oral candidiasis, and back pain.

2. Noctiva

The FDA approved Serenity Pharmaceuticals’ desmopressin acetate nasal spray (Noctiva) on March 3, 2017.
 
The nasal spray is indicated for the treatment of adults who awaken at least 2 times per night to urinate due to nocturia. The drug, taken approximately 30 minutes before going to bed, increases the absorption of water through the kidneys to reduce urine production.
 
Adverse events linked to the use of Noctiva include nasal discomfort, cold symptoms, nasal congestion, sneezing, high or increased blood pressure, back pain, nosebleeds, bronchitis, and dizziness. The FDA also noted that Noctiva should not be used by patients with symptomatic congestive heart failure, uncontrolled hypertension, and certain nasal conditions, and approved the drug with a boxed warning alerting providers to an associated risk of low sodium levels in the blood.

3. Qtern

The FDA approved AstraZeneca’s fixed-dose combination of dapagliflozin and saxagliptin (Qtern) on February 28, 2017.  Qtern, a SGLT-2 inhibitor, is indicated as an adjunct to diet and exercise to improve blood sugar levels in adults with type 2 diabetes (T2D) who have been unable to achieve glycemic control with dapagliflozin or who are already treated with dapagliflozin and saxagiptin.
 
Adverse events associated with the drug’s use include upper respiratory tract infection, urinary tract infection, and dyslipidemia. Qtern is not approved for the treatment of type 1 diabetes or diabetic ketoacidosis.

Learn more about dapagliflozin/saxagliptin to treat inadequately controlled type 2 diabetes here.


4. Bunavail

The FDA expanded the indication of BioDelivery Sciences International's buprenorphine and naloxone buccal film (Bunavail) on May 2, 2017.2
 
Previously approved for the maintenance treatment phase of opioid dependence treatment, Bunavail can now be used for the initiation of buprenophine treatment in opioid-dependent patients. The drug should be used as part of a complete treatment plan that includes counseling and psychosocial support, according to the manufacturer.
 
The most common adverse events reported by patients treated with Bunavail include headache, drug withdrawal syndrome, lethargy, sweating, constipation, decrease in sleep, fatigue, and sleepiness.

5. Victoza

The FDA expanded the indication of Novo Nordisk’s liraglutide (Victoza) on August 25, 2017.5

Initially approved in 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes (T2D), Victoza can now be used to reduce the risk of major adverse cardiovascular events, such as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, in adults with T2D and established cardiovascular disease.

With this nod, the drug is now the only T2D treatment indicated to reduce the risk of major adverse cardiovascular events in adults, according to a Novo Nordisk press release.

The most common adverse events associated with the use of Victoza include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.
Learn more about liraglutide with this quick guide for pharmacists.  

6. Trelegy Ellipta

The FDA approved GlaxoSmithKline and Innoviva’s fluticasone furoate/umeclidinium/vilanterol inhaler (Trelegy Ellipta) on September 18, 2017.4

Trelegy Ellipta is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction. The drug—a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist—is the first once-daily COPD treatment that combines 3 active molecules in a single inhaler to receive the FDA’s nod.

The most common adverse events reported by trial participants treated with Trelegy Ellipta include headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis.
Learn more about Trelegy Ellipta for COPD here.

7. Ingrezza

The FDA approved valbenazine (Ingrezza, Neurocrine Biosciences Inc.) capsules, the first drug approved to treat adults with tardive dyskinesia on April 11, 2017. The drug is taken as 1 capsule, once per day.

On October 6, 2017, the FDA approved an 80-mg capsule strength of valbenazine.

Some adverse effects associated with Ingrezza include sleepiness and heart rhythm problems (QT prolongation).

Here’s what pharmacists should know about treatments for Tardive Dyskinesia.
                                                                                                                                                                                            
8. Shingrix

The FDA approved the zoster vaccine recombinant, adjuvanted (Shingrix, GlaxoSmithKline) on October 20, 2017, for the prevention of herpes zoster in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.

Learn more about the new vaccine here.

9. Ozempic

The FDA has approved Novo Nordisk’s semaglutide injection (Ozempic) on December 5, 2017. Semaglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, according to a company statement.

The once-weekly semaglutide is approved for use in 2 therapeutic dosages: 0.5 mg and 1 mg, and will be launched in the Ozempic pre-filled pen. It should be administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals. 

Treatment with the drug also resulted in statistically significant reductions in body weight, according to the statement. Common adverse events associated with use included mild to moderate nausea, which diminished over time.

10Repatha for Prevention of Cardiovascular Events

On December 4, 2017, the FDA extended the approval of evolocumab (Repatha, Amgen) to include the prevention of heart attacks, strokes, and coronary revascularizations in adults with established heart disease. Evolocumab is the first PCSK9 inhibitor to receive this indication.

Evolocumab is also approved as a monotherapy or in addition to other lipid-lowering drugs to reduce low-density lipoprotein cholesterol among adults with primary hyperlipidemia as an adjunct to diet, according to Amgen.

 

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