New Drugs 2010
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.
Cayston for Cystic Fibrosis
Cayston (Aztreonam) - Gilead - This new form of the antibiotic Aztreonam is given by inhalation aerosol and has been approved for the treatment of lung pseudomonas aeruginosa infections in patients with cystic fibrosis. It has not been approved for patients <7 years of age. Common adverse effects include: cough, nasal congestion, wheezing, throat pain, fever, and chest discomfort.
Cuvposa for chronic drooling in children
Cuvposa (Glycopyrrolate) - Shionogi - Glycopyrrolate is an anticholinergic medication which has been available as both oral and injectable forms for a number of years. This dose form, an oral flavored solution, has been approved for chronic drooling, a problem common in developmentally disabled children ages 3-16. The most common side effects are: dry mouth, constipation and urinary retention.
Ella for emergency birth control
Ella (Ulipristal) - HRA Pharma - this medication is a significant addition to the current therapy as a "morning after pill". It is significantly better that the currently approved Plan B. It acts to prevent ovulation which may occur at the time of intercourse. It provides for a longer contraceptive period than Plan B being effective for five days compared to that of Plan b of three days. Adverse reactions include: nausea, dysmenorrhea, abdominal pain, fatigue and dizziness. It may not be as effective in obese women who wish to prevent pregnancy after intercourse.
Gilenya for multiple sclerosis
Gilenya (Fingolimod) - Novartis - this newly approved drug given orally is a clinically SIGNIFICANT addition to the medications available for the initial treatment of the relapsing forms of multiple sclerosis. The mechanism by which Gilenya exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system. When compared to Interferon beta or placebo, it was significantly better in slowing disease progression and in preventing relapses. Side effects can be serious and include: elevated liver enzymes, elevated blood pressure, shortness of breath, bronchitis, diarrhea and a slow heartbeat.
Jevtana for advanced prostate cancer
Jevtana (Cabazitaxel) - Sanofi - this medication has been approved for the treatment of advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, the current standard of therapy. One study comparing patient who had previously received docetaxel compared men receiving Jevtana and prednisone with another group receiving mitoxantrone and prednisone. The median overall survival with the Jevtana combination was 15.1 months compared with 12.7 months in the mitoxantrone group. Side effects were: decrease in white blood cells, low platelets, diarrhea, fatigue, nausea, weakness and rarely, renal failure.
Krystexxa for chronic gout
Krystexxa (Pegloticase) - Savient - This is the first new addition to the treatment of
chronic gout in a number of years. It is indicated for patients whose gout is
refractory to conventional therapy. Krystexxa is an enzyme that lowers uric acid
levels by metabolizing it into a chemical that is harmless and then passed in the
urine. The drug is administered every two weeks as an intravenous infusion. Two
trials of 212 total patients showed the drug lowered uric acid levels and reduced
deposits of uric acid crystals in joints and soft tissue. Potential serious side effects
include:
Anaphylaxis: Anaphylaxis occurred in patients treated with
KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first
infusion, and generally manifests within 2 hours of the infusion.
Infusion
Reactions: Patients should be pre-medicated with antihistamines and
corticosteroids. Monitor patients closely for signs and symptoms of infusion
reactions.
Gout Flares: An increase in gout flares is frequently observed upon
initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA.
Congestive Heart Failure: KRYSTEXXA has not been formally studied in
patients with congestive heart failure, but some patients in clinical trials
experienced exacerbation. Common adverse reactions (occurring in at least 5% patients) are gout flares, infusion reactions, nausea, contusion or ecchymosis,
nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.
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.
Pradaxa for strokes
Pradaxa (Dabigatran) - Boheringer - Pradexa is an anticoagulant which has specifically been approved to prevent strokes in patients with atrial fibrillation. It acts by inhibiting thrombin, a blood enzyme which promotes clotting. Its advantage over the current standard warfarin is that its use does not require constant monitoring. As with other anticoagulants, patients taking Pradaxa may experience bleeding which can be life-threatening. Other side effects include: gastrointestinal distress such as heartburn and bloating.
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.
Vimovo for arthritis
Vimovo (Naproxen and Esomeprazole magnesium) - Pozen - this combination approved for arthritis pain incorporates the NSAID antiinflammatory activity of naproxen and pantoprazole which is a stomach proton pump inhibitors, which works by reducing the amount of acid in the stomach, The addition of pantoprazole reduces the incidence of gastric irritation and bleeding commonly occurring with the NSAIDS.
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.
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