8 New FDA Approvals to Know from November 2017

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

1. Abilify MyCite

The FDA approved Otsuka Pharmaceutical’s aripiprazole tablets with sensor (Abilify MyCite) on November 13, 2017.¹

Abilify MyCite is indicated for the treatment of schizophrenia, the acute treatment of manic and mixed episodes associated with bipolar I disorder, and use as an add-on treatment for depression in adults. It is the first drug with a digital ingestion tracking system to receive the agency’s nod.

The product works by sending a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Caregivers and physicians can also access this information through a web-based portal.

The most common adverse events associated with the use of Abilify include nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness. Some patients may also experience skin irritation at the site of the MyCite patch placement.

2. Auryxia

The FDA expanded the indication of Keryx Biopharmaceuticals’ ferric citrate tablets (Auryxia) on November 7, 2017.²

Originally approved in September 2014 for the control of serum phosphorus levels in patients with chronic kidney disease who require dialysis, the drug can now be used to treat adults with iron deficiency anemia and chronic kidney disease who are not on dialysis.

Adverse events frequently reported by non-dialysis dependent trial participants treated with Auryxia include diarrhea, constipation, discolored feces, nausea, abdominal pain, and hyperkalemia.

3. Fasenra

The FDA approved AstraZeneca’s benralizumab (Fasenra) on November 14, 2017.³

The drug is indicated for the add-on maintenance treatment of patients with severe eosinophilic asthma aged 12 years and older. With this nod, benralizumab is the only FDA-approved respiratory biologic that provides direct, rapid, and near-complete depletion of eosinophils within 24 hours, according to a manufacturer press release.

Fasenra will be available as a once every 8-week fixed-dose subcutaneous injection via a prefilled syringe.

4. Gazyva

The FDA expanded the indicated of Genentech’s obinutuzumab (Gazyva) on November 16, 2017.⁴

Previously approved for use in combination with bendamustine in patients with follicular lymphoma who have received prior therapy. Gazyva can now be used in combination with chemotherapy, followed by obinutuzumab alone, in patients with advanced follicular lymphoma.

Adverse events associated with the drug’s use include eutropenia, infections, infusion-related reactions, thrombocytopenia, second malignancies, and cardiac events.

5. Hemlibra

The FDA approved Genentech’s emicizumab-kxwh (Hemlibra) on November 16, 2017.⁵

Hemlibra is indicated for the treatment of patients with hemophilia A who have factor VIII inhibitors.

Adverse events frequently reported by trial participants treated with the drug include injection site reactions, headache, and joint pain. Hemlibra carries a boxed warning alerting patients and providers to a potential risk of blood clots in patients given rescue medication for bleeding.

6. Sublocade

The FDA approved Indivior’s injectable buprenorphine (Sublocade) on November 30, 2017.⁶

Sublocade is indicated for the once-monthly treatment of moderate-to-severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product and have been on a stable dose of buprenorphine treatment for at least 7 days.

Although buprenorphine has been previously approved as a tablet, film, or impact, Sublocade is the first injectable buprenorphine product to receive the FDA’s nod.

The most common adverse events associated with the drug’s use of include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching at the injection site, and abnormal liver function tests. Sublocade was approved with a boxed warning against intravenous self-administration, which could cause blockage, tissue damage, or embolus.

7. Sutent

The FDA expanded the indication of Pfizer’s sunitinib malate (Sutent) on November 16, 2017.⁷

Initially approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma, Sutent can now can be taken after the initial surgical removal to lower the risk of cancer recurrence.

The most common adverse effects associated with the drug’s use include fatigue, diarrhea, inflammation of mucous membranes, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia, dyspepsia, and low levels of blood platelets. Sutent carries a boxed warning alerting patients and provider to a potential risk of liver damage.

8. Vraylar

The FDA expanded the indication of Allergan’s cariprazine (Vraylar) on November 13, 2017.⁸

Previously approved for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder, the drug can now be used for the maintenance treatment of adults with schizophrenia.

Adverse events frequently reported by trial participants treated with Vraylar include extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness.

References

• FDA approves pill with sensor that digitally tracks if patients have ingested their medication [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm. Accessed November 13, 2017.
• US FDA approves Auryxia (ferric citrate) tablets as a treatment for people with iron deficiency anemia and chronic kidney disease, not on dialysis [news release]. Keryx Biopharmaceuticals’ website. http://investors.keryx.com/phoenix.zhtml?c=122201&p=irol-newsArticle&ID=2314886. Accessed November 7, 2017.
• Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma [news release]. AstraZeneca’s website. https://www.astrazeneca.com/media-centre/press-releases/2017/fasenra-benralizumab-receives-us-fda-approval-for-severe-uncontrolled-eosinophilic-asthma-14112017.html. Accessed November 15, 2017.
• FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma [news release]. Genentech’s website. https://www.gene.com/media/press-releases/14691/2017-11-16/fda-approves-genentechs-gazyva-for-previ . Accessed November 16, 2017.
• FDA approves new treatment to prevent bleeding in certain patients with hemophilia A [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585567.htm?utm_campaign=11162017_Hemophilia%20A%20treatment&utm_medium=email&utm_source=Eloqua. Accessed November 16, 2017.
• FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587312.htm?utm_campaign=11302017_PR_FDA%20approves%20bunep&utm_medium=email&utm_source=Eloqua. Accessed December 1, 2017.
• FDA expands approval of Sutent to reduce the risk of kidney cancer returning [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm58565htm. Accessed November 17, 201
• Allergan receives FDA approval for use of Vraylar (cariprazine) in the maintenance treatment of schizophrenia [news release]. Allergan’s website. https://www.allergan.com/news/news/thomson-reuters/allergan-receives-fda-approval-for-use-of-vraylar. Accessed November 13, 2017.