5 New Drug Approvals Pharmacy Techs Should Know

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

1. Bevespi Aerosphere

The FDA approved AstraZeneca’s glycopyrrolate and formoterol fumarate (Bevespi Aerosphere) inhalation aerosol on April 25, 2016. The twice-daily, fixed-dose dual bronchodilator is indicated for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD).

Notably, Bevespi Aerosphere is the first FDA-approved combination of a long-acting muscarcinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA) to be administered via a pressurized metered-dose inhaler.

“LAMA/LABAs are emerging as a preferred treatment option for many COPD patients,” said AstraZeneca executive vice president Sean Bohen in a press release. “This class aims to provide maximum bronchodilation, which enables patients to breathe better and may help them be more active.”

The most common adverse event reported by trial participants treated with Bevespi Aerosphere were urinary tract infection and cough.

2. Cabometyx

On April 26, 2016, the FDA approved Exelixis’ cabozantinib (Cabometyx) for the treatment of advanced renal cell carcinoma in patients who have previously received antiangiogenic therapy.

Cabometyx is the first and only FDA-approved product that has demonstrated the ability to slow the progression of renal cell carcinoma—the most common form of kidney cancer in adults—while helping patients live longer, according to a manufacturer press release.

“We are proud to bring new hope to this community, who are looking for more therapies that can help extend lives,” said Exelixis president and CEO Michael Morrissey in the press release.

The most common adverse events experienced by patients treated with the drug include diarrhea, fatigue, nausea, and decreased appetite.

Exelixis hopes to launch Cabometyx in the United States within the next month.

3. Descovy

The FDA approved Gilead Sciences’ emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF) (Descovy) on April 4, 2016.

Descovy is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents in patients aged 12 years and older. However, the FDA noted that the drug should not be used as pre-exposure prophylaxis.

Adverse events associated with the use of Descovy include changes in body fat, immune system changes, new or worsening kidney problems, and some bone issues, such as pain or softening. The drug also has a boxed warning on the risks of lactic acidosis or severe hepatomegaly with steatosis, as well as post-treatment acute exacerbation of hepatitis B.

4. Inflectra

On April 5, 2016, the FDA approved intravenous infliximab-dyyb (Inflectra), a biosimilar to Janssen’s infliximab (Remicade).

Inflectra is the second biosimilar—a biological product that has been found to be extremely similar to an already approved drug—to receive FDA approval, following the 2015 approval of Zarxio.

The drug is indicated for a number of purposes, including the treatment of:

• Moderately to severely active Crohn’s disease in patients aged 6 years and older who have not responded adequately to other therapies
• Moderately to severely active ulcerative colitis in patients who have had inadequate responses to conventional therapy
• Moderately to severely active rheumatoid arthritis in combination with methotrexate;
• Active ankylosing spondylitis
• Active psoriatic arthritis
• Chronic severe plaque psoriasis

The most common adverse effects experienced by trial participants treated with Inflectra include respiratory infections, headache, coughing, and stomach pain. Patients may also experience low or high blood pressure, fever, chills, shortness of breath, rash, itching, and chest pain following infusion.

The drug carries a boxed warning about increased risks of serious infections, such as tuberculosis, bacterial sepsis, and invasive fungal infections. The boxed warning also cautions patients and providers that lymphoma and other potentially fatal malignancies have been reported in children and adolescent patients treated with tumor necrosis factor blockers, such as Inflectra.

5. Venclexta

The FDA has approved AbbVie’s venetoclax (Venclexta) on April 11, 2016.

Venclexta is indicated for the treatment of chronic lymphocytic leukemia in patients who have a chromosomal abnormality called 17p deletion and have already been treated with at least 1 prior therapy. It is the first FDA-approved treatment that targets the B-cell lymphoma 2 protein.

The most common adverse events observed in patients treated with Venclexta include diarrhea, nausea, low red blood cell count, and upper respiratory tract infection. Other potential complications associated with the drug’s use include fertility issues in men, pneumonia, neutropenia with fever, fever, autoimmune hemolytic anemia, anemia, and metabolic abnormalities.

The FDA cautioned providers that patients taking Venclexta should not receive live attenuated vaccines.