5 New FDA Approvals to Know from October 2016


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

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

1.) Amjevita

Last month, the FDA approved Amgen’s adalimumab-atto (Amjevita), a biosimilar to AbbVie’s adalimumab (Humira).

Biosimilars are biological products that are proven to be highly similar to an already-approved biological product and that have no clinically meaningful differences in safety and effectiveness from the reference product. As such, Amjevita can be administered via injection for all indications listed in the label for Humira, including the treatment of:

  • Moderately to severely active rheumatoid arthritis
  • Active psoriatic arthritis
  • Active ankylosing spondylitis (an arthritis that affects the spine)
  • Moderately to severely active Crohn’s disease
  • Moderately to severely active ulcerative colitis
  • Moderate to severe plaque psoriasis

The most common adverse events reported by trial participants treated with Amjevita include injection site reactions and infections, while more serious adverse effects associated with the drug’s use include infection and malignancies. Like Humira, Amjevita was approved with a boxed warning alerting patients and providers to an increased risk of serious infection that may cause hospitalization or death.

2.) Carnexiv

The FDA approved Lundbeck’s carbamazepine (Carnexiv) on October 7, 2016.

The first intravenous formulation of carbamazepine to receive the agency’s nod, Carnexiv is indicated for the short-term (≤7 days) replacement treatment for adults with complex symptomatology, generalized tonic-clonic seizures, mixed seizure patterns, or other partial or generalized seizures who cannot take the oral form of carbamazepine.

Patients who switch to Carnexiv should take 70% of the total daily dose of oral carbamazepine, divided equally into 4 separate 30-minute infusions every 6 hours.

Adverse events associated with the drug’s use include aplastic anemia, agranulocytosis, and serious dermatologic reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome.

Lundbeck plans to launch Carnexiv in the United States in early 2017.

3.) Flublok Quadrivalent

The FDA approved a quadrivalent formulation of Protein Sciences’ Flublok influenza vaccine on October 11, 2016.

Flublok Quadrivalent, the first high-antigen-content quadrivalent flu vaccine to receive the agency’s nod, is indicated for the protection of patients aged 18 years and older against 4 strains of influenza: 3 of the same strains found in its trivalent version, as well as an additional B strain.

Notably, the vaccine contains 3 times more antigen than other traditional flu shots, giving added protection to seniors and patients with compromised immune systems.

Protein Science plans to launch prefilled syringes of Flublok Quadrivalent in 2017.

4.) Lartruvo

The FDA approved Lilly’s olaratumab injection (Lartruvo) on October 19, 2016.

Lartruvo, in combination with doxorubicin, is indicated for the treatment of soft tissue sarcoma (STS) in adults, specifically those who have a histologic subtype for which an anthracycline-containing regimen is acceptable, and those who have not responded to curative treatment with radiotherapy or surgery.

The drug, a platelet-derived growth factor receptor alpha-blocking antibody, works by binding to PDGFR-α and preventing receptor activation. It is the first monoclonal antibody given the FDA’s nod for the treatment of STS.

The most common adverse effects associated with the use of Lartruvo in combination with doxorubicin include nausea, fatigue, musculoskeletal pain, mucositis, vomiting, diarrhea, and headache.

5.) Tecentriq

The FDA approved Genentech’s atezolizumab intravenous injection (Tecentriq) on October 18, 2016.

Tecentriq is indicated for the treatment of metastatic non—small-cell lung cancer (NSCLC) in patients whose disease has progressed during or following platinum-containing chemotherapy, and progressed on an approved targeted therapy if the tumor contains EGFR or ALK gene abnormalities.

The drug, which works by binding to PD-L1 receptors expressed on tumor cells and blocking their interactions with PD-1 and B7.1 receptors, is the first anti-PDL1 cancer immunotherapy to receive the FDA’s nod for metastatic NSCLC.

The most common adverse events reported by trial participants treated with Tecentriq include constipation, cough, decreased appetite, dyspnea, fatigue, musculoskeletal pain, and fatigue. Serious adverse effects associated with the drug’s use include pneumonitis, hepatitis, colitis, hormone gland problems, nervous system problems, eye problems, severe infections, and severe infusion reactions.

The recommended dose of Tecentriq is 1200 mg administered via intravenous infusion over 60 minutes every 3 weeks until the disease progresses or toxicity is deemed unacceptable.

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