5 New FDA Approvals to Know from August 2017

SEPTEMBER 14, 2017
Ryan Marotta, Associate Editor
Learn about the new products and expanded indications approved by the FDA in August 2017.

1. Duzallo
The FDA approved Ironwood Pharmaceuticals’ fixed-dose combination of lesinurad and allopurinol (Duzallo) on August 21, 2017.1

Duzallo is indicated for the treatment of hyperuricemia in patients with uncontrolled gout. The drug, designed to achieve target serum uric acid (sUA) levels in patients who cannot do so with allopurinol alone, is the first FDA-approved fixed-dose combination oral treatment that addresses both over-production and under-excretion of sUA in a single medication.

The most common adverse events associated with the use of Duzallo include headache, influenza, higher levels of blood creatinine, and heartburn. The drug also has a boxed warning alerting patients and providers to a risk of acute renal failure.

Ironwood Pharmaceuticals plans to launch Duzallo in the United States during the fourth quarter of 2017.

2. Idhifa
The FDA approved Celgene Corporation’s enasidenib (Idhifa) on August 1, 2017.2

Idhifa is indicated for the treatment of relapsed or refractory acute myeloid leukemia (AML) in adult patients with an isocitrate dehydrogenase-2 (IDH2) genetic mutation. The drug is to be used alongside the RealTime IDH2 Assay, a companion diagnostic from Abbott Laboratories that is used to detect specific mutations in the IDH2 gene in patients with AML.

Common adverse events reported by trail patients treated with Idhifa include nausea, vomiting, diarrhea, increased levels of bilirubin, and decreased appetite. The drug should not be used by pregnant women.

3. Mavyret
The FDA approved AbbVie’s glecaprevir and pibrentasvir (Mavyret) on August 3, 2017.3

Mavyret is indicated for the treatment of patients with chronic hepatitis C (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis, including those with moderate-to-severe kidney disease and those who are on dialysis.

The drug can also be used to treat adult patients with an HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5a inhibitor or an NS3/4A protease inhibitor, but not both.

The most common adverse events associated with the use of Mavyret include headache, fatigue, and nausea. The drug’s is contraindicated in patients with severe cirrhosis, and its use is not recommended in those with moderate cirrhosis.

4. Vapomere
The FDA approved Rempex’s meropenem and vaborbactam injection (Vapomere) on August 29, 2017.4

Rempex is indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adults.

The most common adverse effects reported by trial participants treated with Vabomere include headache, site reactions, and diarrhea. The drug is also associated with a risk of allergic reaction, and should not be taken by patients with a history of anaphylaxis.

Vabomere has been designated as a qualified infectious disease product, and should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

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.

  1. Ironwood Pharmaceuticals announces FDA approval of Duzallo (lesinurad and allopurinol) for the treatment of hyperuricemia in patients with uncontrolled gout [news release]. Ironwood Pharmaceuticals’ website. http://news.ironwoodpharma.com/phoenix.zhtml?c=228069&p=irol-newsArticle&ID=2294774. Accessed August 21, 2017.
  2. FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569421.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed August 1, 2017.
  3. FDA approves Mavyret for Hepatitis C [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm570038.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed August 3, 2017.
  4. FDA approves new antibacterial drug [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573955.htm. Accessed August 30, 2017.
  5. Victoza approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of major adverse cardiovascular events [news release]. Novo Nordisk’s website. https://www.novonordisk.com/media/news-details.2129162.html. Accessed August 25, 2017.