8 New Drug Approvals Pharmacy Techs Should Know

Learn about the new drugs and expanded indications approved by the FDA in March 2016.

1. Anthim

The FDA approved Elusys Therapeutics’ obiltoxaximab (Anthim) injection on March 18, 2016.

Anthim is indicated for the treatment of inhalational anthrax in combination with appropriate antibacterial medications. The drug may also be used to prevent inhalational anthrax when other therapies are inappropriate or unavailable.

The most common adverse events associated with the use of Anthim include headache, itching, upper respiratory tract infections, cough, nasal congestion, hives, and bruising and pain at the infusion site. The drug also has a boxed warning about its risks for allergic reactions, including anaphylaxis.

Given the seriousness and potential deadliness of anthrax, the FDA noted that these risks are likely outweighed by the drug’s benefits.

2. Cinqair

On March 23, 2016, the FDA approved Teva’s reslizumab (Cinqair) for the maintenance treatment of severe asthma, along with other asthma medications, in patients aged 18 years or older.

The drug may also be prescribed to patients who have a history of severe asthma exacerbations, despite their current asthma medication.

Cinqair is administered once every 4 weeks by a health care professional in a clinical setting that is set up to handle anaphylaxis. The humanized interleukin-5 antagonist monoclonal antibody works by reducing the eosinophil levels in the blood, limiting severe asthma attacks.

Common adverse events associated with the use of Cinqair include anaphylaxis, cancer, and muscle pain.

3. Defitelio

The FDA gave its first nod to a veno-occlusive disease treatment last month when it approved Jazz Pharmaceuticals’ defibrotide sodium (Defitelio) on March 30, 2016.

Specifically, Defitelio is indicated for the treatment of hepatic veno-occlusive disease in adults and children who have additional kidney or lung abnormalities following hematopoietic stem cell transplantation.

The most common adverse events associated with the drug’s use include low blood pressure, nausea, diarrhea, vomiting, and nose bleeds. Severe side effects such as bleeding and allergic reactions have also been observed in trial participants.

Additionally, Defitelio should not be used in patients who have experienced bleeding complications or are taking blood thinners.

4. Evomela

On March 15, 2016, the FDA expanded label of Spectrum Pharmaceuticals’ melphalan (Evomela), approving the drug for the palliative treatment of patients with multiple myeloma for whom oral therapy isn’t appropriate.

The agency also permitted the drug to be used as a high-dose conditioning treatment prior to hematopoietic progenitor cell transplantation in patients with multiple myeloma. With this nod, Evomela is now the first and only product to be approved for a high-dose conditioning indication for multiple myeloma.

The most common adverse effects associated with the drug’s use include decreased neutrophil count, decreased white blood cell count, fatigue, diarrhea, and nausea.

5. Ibruvica

The FDA expanded the indication of Janssen Biotech’s ibrutinib (Ibruvica) on March 4, 2016, approving the drug for the treatment-naïve patients with chronic lymphocytic leukemia (CLL).

Imbruvica was initially approved in 2014 for the treatment of CLL in patients who had received at least 1 prior therapy. Later that year, the drug’s indication was expanded to include CLL patients with a deletion in chromosome 17, a mutation that frequently led to poor treatment outcomes.

With this latest FDA nod, Imbruvica can be used in all lines of CLL therapy.

The most common adverse effects associated with the drug’s use include diarrhea, muscle and bone pain, tiredness, and nausea.

6. Odefsey

The FDA approved Gilead’s emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg (Odefsey) on March 1, 2016.

Odefsey is indicated for the treatment HIV-1 infection in patients aged 12 years and older who have no antiretroviral treatment history and have HIV-1 RNA levels ≤100,000 copies/mL.

The drug can also be used as a replacement for a stable antiretroviral regimen in patients who are virologically suppressed for at least 6 months with no history of treatment failure.

Notably, Odefsey is the smallest pill of any single-tablet regimen for HIV.

The treatment was approved with a boxed warning about its risks for lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.

7. Taltz

On March 22, 2016, the FDA approved Lilly’s ixekizumab (Taltz) as a treatment for moderate to severe plaque psoriasis.

Designed for use in both systemic therapy and phototherapy, Taltz is administered to patients as an injection. The drug works by binding to a patients’ interleukin 17A protein, thereby reducing inflammation.

The most common adverse events associated with the use of Taltz include upper respiratory tract infection, fungal infection, and injection site reactions. Serious allergic reactions and worsening inflammatory bowel disease have also been observed in trial participants treated with the drug.

8. Xalkori

The FDA expanded the indication of Pfizer’s crizotinib (Xalkori) on March 11, 2016, approving the drug for the treatment of patients with advanced non-small cell lung cancer whose tumors have an ROS-1 gene alteration.

The first medication to receive the agency’s nod for this purpose, Xalkori works by inhibiting the ROS-1 protein in tumors that have ROS-1 gene alterations, potentially preventing the cancer’s growth.

The most common adverse events associated with the use of Xalkori include nausea, vision disorders, diarrhea, vomiting, and swelling. However, the FDA noted that severe side effects such as liver problems, abnormal heartbeats, and inflammation in the lungs could also occur.