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Monthly News Roundup - April 2016

First-Time Generic Approved for Statin Crestor

High cholesterol, high low-density lipoprotein (LDL) or “bad cholesterol”, and triglycerides increase the risk for serious heart disease and may lead to heart attacks and strokes. The FDA has now approved the first generic version for Crestor, known by the generic name of rosuvastatin. Rosuvastatin was approved for three uses: high triglycerides in addition to diet; primary dysbetalipoproteinemia (improper breakdown of cholesterol and triglycerides) in addition to diet; and alone or with other cholesterol treatments for adult homozygous familial hypercholesterolemia, (high LDL cholesterol). Common side effects include headache, muscle pain, stomach pain, weakness, and nausea. Rosuvastatin should not be used during pregnancy or breastfeeding.

Inflectra: A Second U.S. Biosimilar is FDA-Approved

The biosimilar market is growing. The US Food and Drug Administration (FDA) has cleared the second U.S. biosimilar, Inflectra (infliximab-dyyb) by Celltrion. Inflectra, a tumor necrosis factor (TNF) blocker, is biosimilar to Janssen’s Remicade (infliximab) originally approved in 1998. Inflectra can be prescribed for the same indications as Remicade, including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis (spine arthritis), ulcerative colitis, psoriatic arthritis, and plaque psoriasis. The first US biosimilar, Zarxio (filgrastim-sndz) from Sandoz, was approved in March 2015.

Nuplazid is First Drug Available for Parkinson’s Disease Psychosis

The FDA has approved Acadia’s once-daily Nuplazid (pimavanserin) tablets, the first atypical antipsychotic to treat hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). Nuplazid shows no measurable activity at dopaminergic receptors. Nuplazid exhibits inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors. In a six-week study of 199 patients, Nuplazid was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease. Common side effects include: swelling (peripheral edema), nausea, and confusion. Nuplazid can also lead to QT interval prolongation.

Descovy: FDA Approves Gilead’s Third TAF-Based HIV Therapy

The FDA has approved Gilead’s Descovy (emtricitabine and tenofovir alafenamide [TAF]), a nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination for the treatment of HIV-1 infection. TAF provides lower levels of drug in the blood, but higher levels within the cells where HIV-1 replicates. TAF was developed to help reduce some drug side effects linked with regular tenofovir like kidney toxicity and decreases in bone density. Descovy is used with other antiretroviral agents in adults and children 12 years and older. Genvoya and Odefsey are other HIV-1 treatments from Gilead approved in the last 6 months that also contain TAF.

Carbometyx Now Approved for Advanced Kidney Cancer

Renal cell carcinoma (RCC) is the most common form of kidney cancer in adults. Cabometyx (cabozantinib), an oral multikinase inhibitor, is now approved for the treatment of patients with advanced RCC who have received prior anti­-angiogenic therapy. In the phase 3 METEOR trial and as published in the New England Journal of Medicine, Cabometyx was associated with a 42 percent reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months versus 3.8 months for everolimus. Common side effects for Cabometyx include diarrhea, fatigue, nausea, decreased appetite, hand-foot syndrome, high blood pressure, vomiting, weight loss, and constipation.

AstraZeneca’s Bevespi Aerosphere Wins Approval for COPD

Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) is a long-acting, fixed dose beta2-adrenergic agonist (LABA) and anticholinergic combination approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Bevespi Aerosphere is used twice a day via a pressurized metered dose inhaler (pMDI). In studies, Bevespi Aerosphere achieved lung function endpoints (significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks) compared to it’s individual agents and placebo. There were no unexpected safety findings; however, common side effects included cough.

Targeted Therapy Venclexta Granted FDA Approval for Rare Type of CLL

In the fight against leukemia, the U.S. Food and Drug Administration (FDA) has approved AbbVie's Venclexta (venetoclax), a oral B-cell lymphoma-2 (BCL-2) inhibitor for chronic lymphocytic leukemia (CLL) with 17p deletion, a chromosomal abnormality detected with a FDA-approved diagnostic test. In patients, the CLL cancer cell growth is fed by the BCL-2 protein, but the new drug inhibits this protein. In a study, 106 patients took increasing doses of the Venclexta pill once a day for five weeks. Results showed that 80% of patients either saw improvement or their cancer fully disappear. Common side effects included low red and white blood cell count, diarrhea, nausea, and respiratory infections.

Posted: April 2016