New Drugs 2010

2009 | 2008 | 2007 |2006 | 2005 | 2004 | 2003
2002 | 2001 | 2000 | 1999 | 1998 | 1997

Arzerra for Chronic Lymphocytic Leukemia

Arzerra (Ofatumumab) - GSK - this newly approved drug has been approved for the treatment of fludarabine-resistant chronic lymphocytic leukemia (CLL). In a study involving 138 patients, a partial response rate of 58% was observed in those with double resistant (fludarabine and alemtuzumab) CLL and 47% in those who had lymphatic bulky tumor masses. The progression-free survival was 5.7 mo. and 5.9 months respectfully. The most common adverse effects were infusion related reactions such as fever, diarrhea,rash,fatigue. Less common were upper respirators tract infections, pneumonia, anemia, and difficulty breathing.

Actemra for rheumatoid arthritis

Actemra (Tocilizumab) - Genentech - this new injectable drug has been approved for moderate to severe rheumatoid arthritis (RA). It acts by inhibiting the inflammatory-promoting activity of interleukin-6. It is indicated for those patients whose disease has not been controlled by other therapies for RA. The most serious side effect is the occurrence of serious infections that can lead to hospitalization or death. Less serious side effects include: upper respiratory tract infection, inflammation of the niose and throat, headache, and high blood pressure.

Ampyra for Multiple Sclerosis

Ampyra (Dalfampridine) - Acorda - this is a significant new addition to the therapies available for the treatment the difficulty in walking characteristic of multiple sclerosis. It acts by blocking potassium channels in the muscles. It is effective in all forms of multiple sclerosis.

Because of its narrow therapeutic index doses greater than 10mg twice daily are not recommended. The significant side effects seen with higher doses is seizures. Side effects with normal dosing include:uninary tract infections,insomnia,dizziness, back pain, diarrhea, and tingling or itching of the skin.

Asclera for varicose veins

Asclera (Polidocanol) - Bioform Medical - this newly approved drug is unique in its indications and action. It has been approved for the treatment of small varicose veins (Spider and Reticular). It is injected directly into the area of the varicose vein and injures the lining of the vein. This injury results in the vein sealing itself off and disappearing. Side effects are limited to:the appearance of a bruise at the injection site, irritation, discoloration at the injection site.

Carbaglu for N-acetylglutamate deficiency

Carbaglu (Carglumic Acid) - Orphan Europe - Carbaglu is indicated for the treatment of N-acetylglutamate (NAG) deficiency, a hereditary disease leading to high levels of ammonia. These high levels in the brain leads to permanent and irreversible damage. Carbaglu is a synthetic analogue of NAG and it prevents the buildup of ammonia in the blood and central nervous system. Treated patient have normal neurological development.

Lumizyme for Pompe disease

Lumizyme (Alglucosidase) - Genzyme - Pompe disease is characterized by a gene mutation which prevents the body from making enough acid alpha-gluosidase (GAA). Lumizyme which acts by supplementing the deficient GAA Is the first drug approved to treat this disabling disease. It has been approved only for patients 8 years and older. Side effects include severe allergic reactions including hives, shortness of breath, partial hearing loss, flushing nausea and diarrhea.

Menveo for prevention of meningoccal disease

Menveo(TM) (MenACWY-CRM) - Novartis - this vaccine is indicated for the prevention of meningococcal disease caused by Neisseria meningitides, Serotypes A, C, Y, and W-135. It is approved for use in persons 11 to 55 years of age.

Prevnar 13 for prevention of S. pneumoniae infections

Prevnar 13 (Pneucoccal 13-valent conjugate vaccine) - Prevnar is indicated for the prophylaxis of infections (mostly lung) due to Streptococcus pneumoniae in children 6 week through 5 years of age.

Prolia for osteoporosis

Prolia (Denosumab) - Amgen - this is a new addition to the many drugs available for the prevention of postmenopausal osteoporosis. It differs from the others in requiring and injection every six months. Clinical studies demonstrated Prolia resulted in greater bone density, stronger bones, and reduced risk for back (vertebral), hip and non-vertebral fractures. A major side effect was the increased incidence of serious skin infections. Other more common side effects were: back pain,muscular and skeletal pain and inflammation of the bladder (cystitis).

Provenge for prostate cancer

Provenge (Sipuleucel-T) - Dendreon - this novel new treatment for advanced prostate cancer is an immunostimulant which is designed to stimulate a patients own immune system to attack and kill the malignant prostate cancer cells. Each dose is designed for a specific patient by using the patients own blood-derived immune cells and then exposing them to a protein found in most malignant prostate cells. This then stimulates an immune response in the patients isolated immune cells. The stimulated cells are then reinjected into the patient and target the same malignant prostate cancer cells they were exposed to in the laboratory. Patient so treated had a median survival of 25.8 months compared to 21.7 months for those treated with a placebo injection. Side effects were common with chills,fatigue,back pain and headache reported most frequently. Cerebrovascular events including hemorrhagic and ischemic strokes were see in 3.5% of patients.

Victoza for type 2 diabetes.

Victoza (Liraglutide) - Novo Nordisk - Victoza joins the ever expanding drugs available for the treatment of Type 2 diabetes. It is the first once-daily injectable human Glucagon-Like Peptide-1 (GLP-1) analogue approved for this use. The most severe side effect is pancreatitis (inflammation of the pancreas) which occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Thus, Victoza should be stopped if patients experience severe abdominal pain, with or without nausea and vomiting, The most common side effects observed with Victoza in the clinical trials were headache, nausea, and diarrhea. Other side effects included allergic-like reactions such as hives.

VPRIV for Gauchers Disease

VPRIV (Velaglucerase) - Shire - this is a significant addition to the medications available for the treatment of inborn errors of metabolism. VPRIV has been approved for the treatment of Type 1 Gaucher disease. It is a human cell line-derived replacement for Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. Without this enzyme, harmful amounts of a certain fatty substance (lipid) can build up in the liver, spleen, bones, bone marrow and nervous system, and can prevent cells and organs from working properly. The most common adverse reactions are allergic reactions. Other observed were headache, dizziness, abdominal pain, back pain, joint pain, nausea, fatigue/weakness, fever, and prolongation of activated partial thromboplastin time, a measure of clotting time.

Xiaflex for Dupuytren’s contracture

Xiaflex (Collagenase Clostridium Histolyticum) - Auxilium Pharmaceuticals - this unique drug is indicated for the treatment of Duputren’s contracture, a condition resulting from an abnormal buildup of collagen in the connective tissue of the palms and hands. When most severe the collagen buildup forms rope-loke cords that causes the fingers to curl. In a study of 306 patients whose fingers were curled, 64% achieved finger mobility comared with 7% with placebo.