New Drugs 2012
Bydureon for Type 2 diabetes
Bydureon (Exenatide) - Amylin Pharmaceuticals - this new addition to the drugs to control blood glucose levels in diabetic patients. It is unique in that following an injection, its hypoglycemic effects last for 1 week. Because of the findings in animal studies Amylin has created a registry for the purpose of determining whether Bydureon may produce medullary thyroid cancer.
Approved January 27, 2012
Erivedge for Advanced Basal cell carcinoma
Erivedge (Vismodegib) - Genentech - Erivedge has been approved for locally advanced basal cell carcinoma who are not canadidates for surgery and/or radiation and for patients whose basal cell carcinoma has spread to other parts of the body. Taken by mouth, Erivedge acts by inhibiting the Hedgehog pathway. Activation of the hedgehog pathway is required for transition of the hair follicle from the resting to the growth phase. In a clinical study of 96 patients, 30% of those with metastatic disease experienced a partial response and 43% with locally advanced disease experienced a complete of partial response. Side effects were muscle spasms, hair loss, weight loss, nausea, change in sense of taste, decreased appetite, and fatigue.
Approved January 30, 2012
Kalydeco for cystic fibrosis
Kalydeco (Ivacaftor) - Vertex - this is the first drug specifically approved for the treatment of cystic fibrosis. It is effective only when patients with cystic fibrosis carry the G551D mutation in the CF membrane regulator (CFTR) gene. Although the number of children it may benefit is limited the fact that it is the first drug found to be effective albeit in a small number of patients is a significant forward step in treating this deadly disease.
Korlym for Cushings Syndrome
Korlym (Mifepristone) - Corcept Therapeutics - Korlym has been approved for the treatment of the high blood sugar levels in adults with endogenous Cushing?s syndrome and is the first drug to be approved for that use. In a clinical trial of 50 patients there was a significant lowering of blood sugar levels and some patients had significant reductions in their insulin requirements. Common side effects included: nausea, fatigue, headache, swelling of the extremities and decreased appetite. There is a BLACK BOX warning that Korlym shoud not be used in pregnancy.
Approved 02/17/12
Omontys for anemia of chronic kidney disease
Omontys (Peginsatide) - Affymax - This is the first drug since 2001 to be approved for the treatment of anemia in patients undergoing hemodialysis for chronic kidney disease. It acts by stimulating the bone marrow to product more red blood cells. Given subcutaneously every month, hemoglobin levels of 20-12g/dl were maintained in the majority of patients. The most common side effects were: diarrhea, vomiting , hypertension, and aching of the joints.
Approved 03/27/12
Surfaxin for Respiratory Distress Syndrome in Infants
Surfaxin (Lucinactant) - Discovery Laboratories - The FDA recently approved this unique drug for the syndrome of respiratory distress in newborns (RDS). Surfaxin is a synthetic surfactant. Normal lungs produce surfactant which coats the insides of the lungs and helps to keep the small airways open. Premature infants often do not produce enough natural surfactant to adequately coat their small airways. Suirfaxin mimics the natural surfactant and prevents those infants from developing RDS.
Approved 03/06/12
Voraxaze for methotrexate toxicity
Voraxaze (Glucarpidase) - BTG International - It is a recombinent enzyme that rapidly converts methotrexate to a much less toxic metabolite. In one clinical study Voraxaze was able to reduce the methotrxate serum levels by 95%. Side effects included hypotension, headache, nausea, vomiting, flushing and extremity numbness.
Approved Jan. 27, 2012
Zioptan for glaucoma
Zioptan (Tafluprost) - Merck - this newly approved medication joins a number of other drugs approved for open-angle glaucoma. The fact it does not contain a preservative is an advantage over others in its therapeutic field.
Approved 02/13/12
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