7 New FDA Approvals to Know from February 2017

Learn about the new products and expanded indications approved by the FDA in February 2017.

1. Emflaza

The FDA approved Marathon Pharmaceuticals’ deflazacort (Emflaza) tablets and oral suspension on February 9, 2017.¹

Emflaza is indicated for the treatment of Duchenne muscular dystrophy, a rare genetic disorder, in patients aged 5 years and older. The drug is the first corticosteroid to receive the FDA’s nod for this purpose.

Adverse events associated with the use of Emflaza include facial puffiness, weight gain, increased appetite, upper respiratory tract infection, cough, extraordinary daytime urinary frequency, unwanted hair growth, and excessive fat around the stomach.

2. Parsabiv

The FDA approved Amgen’s etelcalcetide (Parsabiv) on February 7, 2017.²

Parsabiv is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. It is the first such therapy to receive the FDA’s nod for this purpose in 12 years.

The drug, which is administered intravenously 3 times a week at the end of each hemodialysis session, works by binding to and activating the calcium-sensing receptor on the parathyroid gland, enabling it to decrease parathyroid hormone (PTH) levels.

The most common adverse events reported by trial patients treated with Parsabiv include blood calcium decrease, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia. The drug’s use is not recommended in patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis.

3. Qtern

The FDA approved AstraZeneca’s fixed-dose combination of dapagliflozin and saxagliptin (Qtern) on February 28, 2017.³

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.

4. Siliq

The FDA approved Valeant Pharmaceuticals’ brodalumab (Siliq) on February 15, 2017.⁴

Siliq is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and who have failed to respond to other systemic therapies.

Injected subcutaneously, the drug works by targeting the IL-17 receptor in patients, preventing the body from receiving signals that may lead to inflammation and skin cells accumulation.

Adverse effects reported by trial participants treated with Siliq include headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea. The drug was approved with a Risk Evaluation and Mitigation Strategy, as well as with a boxed warning alerting patients and providers to further risks observed in patients with a history of suicidal thoughts or behavior.

5. Spiriva Respimat

The FDA expanded the indication of Boehringer Ingelheim Pharmaceuticals’ tiotropium bromide inhalation spray (Spiriva Respimat) on February 16, 2017, allowing the drug to be used as a long-term, once-daily asthma treatment in patients aged 6 years and older.⁵

Spiriva Respimat was initially approval in September 2014 for the treatment of chronic obstructive pulmonary disease (COPD) in patients 12 years and older. In September 2015, the drug also received the FDA’s nod for the treatment of asthma in patients 12 years and older.

Adverse events associated with the use of Spiriva Respimat in patients with asthma include sore throat, sinus infection, bronchitis, and headache. The drug does not contain steroids, and is not to be used a treatment for sudden asthma symptoms

6. Trulicity

The FDA updated the label of Eli Lilly’s dulaglutide injection (Trulicity) on February 8, 2017, permitting the drug to be used in combination with basal insulin to achieve greater blood sugar control in adults with T2D.⁶

Trulicity, a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist, was initially approved with a Risk Evaluation and Mitigation Strategy in September 2014; at that time, the FDA requiring Lilly to conduct several post-marketing studies on the drug’s safety and efficacy.

With this latest nod, Trulicity is the first medication of its class allowed to be used in combination with mealtime insulin or basal insulin.

The most common side effects reported by trial patients treated with Trulicity included nausea, diarrhea, vomiting, abdominal pain, and decreased appetite. The drug also has a boxed warning alerting patients and prescribers to a potential risk of thyroid tumors.

7. Xermelo

The FDA approved Lexicon Pharmaceuticals’ telotristat ethyl tablets (Xermelo) on February 28, 2017.⁷

Xermelo is indicated, in combination with somatostatin analog (SSA) therapy, for the treatment of adults with carcinoid syndrome diarrhea that is not adequately controlled by SSA therapy alone.

The drug works by inhibiting carcinoid tumors’ production of serotonin, reducing the frequency of carcinoid syndrome diarrhea.

The most common adverse events associated with the use Xermelo include nausea, headache, increased levels of the liver enzyme gamma-glutamyl transferase, depression, accumulation of peripheral edema, flatulence, decrease appetite, and fever. The drug may also cause constipation, especially in patients whose bowel movement frequency is less than 4 bowel movements per day.

References

• FDA approves drug to treat Duchenne muscular dystrophy [news release]. FDA’s website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm540945.htm. Accessed Feb. 9, 2017.
• FDA Approves Amgen's Parsabiv (Etelcalcetide), first new treatment in more than a decade for secondary hyperparathyroidism in adult patients on hemodialysis [news release]. California. Amgen’s website. http://www.amgen.com/media/news-releases/2017/02/fda-approves-amgens-parsabiv-etelcalcetide-first-new-treatment-in-more-than-a-decade-for-secondary-hyperparathyroidism-in-adult-patients-on-hemodialysis/. Accessed Feb. 8, 2017.
• FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type 2 diabetes [news release]. Astrazeneca’s website. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2017/fda-approves-once-daily-qtern-dapagliflozin-and-saxagliptin-tablets-for-adults-with-type-2-diabetes-240217.html. Accessed Feb. 28, 2017.
• FDA approves new psoriasis drug [news release]. FDA’s website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm541981.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed Feb. 15, 2017.
• FDA Expands Approval of Spiriva Respimat (tiotropium bromide) inhalation spray for maintenance treatment of asthma in children [news release]. http://www.prnewswire.com/news-releases/fda-expands-approval-of-spiriva-respimat-tiotropium-bromide-inhalation-spray-for-maintenance-treatment-of-asthma-in-children-300408750.html. Accessed Feb. 16, 2017.
• Lilly's Trulicity® (dulaglutide) Label Updated to include use in combination with basal insulin for adults with type 2 diabetes [news release]. Indianapolis. Eli Lilly’s website. https://investor.lilly.com/releasedetail.cfm?ReleaseID=1010933. Accessed Feb. 8, 2017.
• FDA approves Xermelo for carcinoid syndrome diarrhea [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544035.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed Mar. 1, 2017.