7 New FDA Approvals to Know from December 2016

Learn about the new products and expanded indications approved by the FDA in December 2016.

1. Avastin

The FDA expanded the indication of Roche’s bevacizumab (Avastin), on December 7, 2016.

Initially approved for the treatment of metastatic colorectal cancer, Avastin can now be used either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy for the treatment of women with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The drug can also be used for the treatment of several types of lung cancer, brain cancer, kidney cancer, and cervical cancer.

The most common adverse events reported by trial participants treated with Avastin and chemotherapy included thrombocytopenia, nausea, dyspnea, epistaxis, hypertension, fatigue, febrile neutropenia, proteinuria, abdominal pain, hyponatraemia, headache, and extremity pain.

2. Eucrisa

The FDA approved Anacor Pharmaceuticals’ crisaborole ointment (Eucrisa) on December 14, 2016.

Eucrisa, a phosphodiesterase 4 (PDE-4) inhibitor, is indicated for the twice-daily treatment of atopic dermatitis, a common type of eczema, in patients aged 2 years and older.

The most common adverse event associated with the drug’s use was application site pain, including burning or stinging. The FDA acknowledged that some trial participants also experienced hypersensitivity reactions, and warned that Eucrisa should not be used in patients with a history of such reactions to the drug’s active ingredient, crisaborole.

3. Jardiance

The FDA expanded the indication of Boehringer Ingelheim’s empagliflozin (Jardiance) on December 2, 2016.

Initially approved to improve glycemic control in adults with type 2 diabetes (T2D), Jardiance can now also be used to reduce the risk of cardiovascular death in adult patients with T2D and cardiovascular disease.

The most common adverse events experienced by trial participants treated with Jardiance included urinary tract infections and female genital infections. The drug’s use has also been linked with dehydration, hypotension, ketoacidosis, serious urinary tract infection, acute kidney injury, renal function impairment, hypoglycemia when used with insulin or insulin secretagogues, genital mycotic infections, and increased cholesterol.

Additionally, Jardiance is not intended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The drug’s use is contraindicated in patients with a history of serious hypersensitivity reactions to Jardiance, severe renal impairment, end-stage renal disease, or dialysis.

4. Rubraca

On December 19, 2016, the FDA approved Clovis Oncology’s rucaparib (Rubraca) for the treatment of advanced ovarian cancers in women whose tumors have a specific gene mutation (deleterious BRCA).

The agency also gave its nod to the FoundationFocus CDxBRCA companion diagnostic for use with Rubraca. The test, the first next-generation-sequencing-based companion diagnostic to receive the FDA’s approval, is designed to detect the presence of deleterious BRCA gene mutations in tumor tissue.

Adverse effects experienced by trial participants treated with Rubraca include nausea, fatigue, vomiting, low red blood cell levels, abdominal pain, unusual taste sensation, constipation, decreased appetite, diarrhea, low blood platelet levels, and trouble breathing. The drug’s use is also associated with more serious risks such as bone marrow problems, acute myeloid leukemia, and fetal harm.

5. Spinraza

The FDA approved Biogen’s nusinersen (Spinraza) on December 23, 2016.

Spinraza, which is administered via injection into the fluid surrounding the spinal cord, is indicated for the treatment of spinal muscular atrophy in children and adults.

The most common adverse effects associated with the drug’s use are upper respiratory infection, lower respiratory infection, and constipation. Patients treated with Spinraza may also experience low blood platelet count and toxicity to the kidney toxicity.

6. Synjardy XR

The FDA approved Synjardy XR Boehringer Ingelheim and Lilly’s extended-release empagliflozin and metformin hydrochloride tablets (Synjardy XR) on December 12, 2016.

Synjardy XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. In combination with diet and exercise, can improve blood sugar in patients.

The most common adverse events associated with the drug’s use include stuffy or runny nose, sore throat, urinary tract infections, female genital infections, diarrhea, headache, nausea, and vomiting. Patients treated with Synjardy XR may also face an increased risk of dehydration and ketoacidosis.

7. Tresiba

The FDA expanded the indication of Novo Nordisk’s insulin degludec injection (Tresiba) on December 19, 2016.

With this latest nod, Tresiba is now indicated for the once-daily treatment of type 1 and type 2 diabetes in children aged 1 year and older. Previously, the drug’s use was permitted only in adults.

The most common adverse events reported by trial participants treated with Tresiba include were infection, hypoglycemia, and hyperglycemia.

Tresiba is available in FlexTouch, Novo Nordisk's latest insulin delivery device, as 100 units/mL or 200 units/mL pens.