New FDA Approved Drugs from 1st Quarter 2015
New medications are now approved to treat certain cancers, HIV, heart disease and even submental fat. The U.S. Food and Drug Administration approved these drugs in the first quarter of the year:
Corlanor (ivabradine) is used to reduce hospitalization from worsening heart failure. Corlanor is approved for use in certain people who have chronic heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate.
Farydak (panobinostat) is used for the treatment of patients with multiple myeloma – a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. According to the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma and 10,710 die from the disease annually. Farydak works by inhibiting the activity of enzymes, known as histone deacetylases (HDACs). This process may slow the over-development of plasma cells in multiple myeloma patients or cause these dangerous cells to die. Farydak is the first HDAC inhibitor approved to treat multiple myeloma. It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication.
Evotaz is comprised of atazanavir and cobicistat. Aatazanavir is a protease inhibitor antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body. Cobicistat reduces the action of enzymes in your liver that break down certain antiviral medicines. This allows the antiviral medicines to be used more safely and effectively at lower doses. Evotaz is given together with other antiviral medicines to treat HIV in adults. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.
Avycaz (ceftazidime-avibactam) This new antibacterial drug product is used to treat adults with complicated intra-abdominal infections (cIAI)C, in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
Duopa (carbidopa and levodopa) enteral suspension is for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. Duopa is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally-placed tube.
Ibrance (palbociclib) is approved for the treatment of ER-positive, HER2-negative breast cancer. Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells. Ibrance is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole, another FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women.
Lenvima (lenvatinib) is a new treatment for thyroid cancer in patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.
Opdivo (nivolumab) for the treatment of advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. Opdivo is intended for patients who have previously been treated with platinum-based chemotherapy.
Unituxin (dinutuximab) for the treatment of pediatrics with high-risk neuroblastoma. Neuroblastoma is a rare cancer that forms from immature nerve cells. It usually begins in the adrenal glands but may also develop in the abdomen, chest or in nerve tissue near the spine. Neuroblastoma typically occurs in children younger than five years of age. According to the National Cancer Institute, neuroblastoma occurs in approximately one out of 100,000 children and is slightly more common in boys. There are an estimated 650 new cases of neuroblastoma diagnosed in the United States each year. Patients with high-risk neuroblastoma have a 40 to 50 percent chance of long term survival despite aggressive therapy. Unituxin is an antibody that binds to the surface of neuroblastoma cells. Unituxin is being approved for use as part of a multimodality regimen, including surgery, chemotherapy and radiation therapy for patients who achieved at least a partial response to prior first-line multiagent, multimodality therapy.
Kybella (deoxycholic acid) is a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended. Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart.
Source: U.S. Food and Drug Administration