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Monthly News Round Up - March 2013

Tecfidera FDA-Approved for Multiple Sclerosis

Multiple sclerosis (MS) is a central nervous system disease that disrupts communication between the brain and other parts of the body. MS, which results in muscle weakness and difficulty with coordination and balance, affects close to 400,000 people in the U.S. The U.S. Food and Drug Administration has approved Tecfidera (dimethyl fumarate), also known as BG-12, an oral, twice daily Nrf2 pathway activator for the treatment of relapsing-remitting multiple sclerosis. Tecfidera may decrease white blood cell (WBC) counts; baseline and annual WBC counts are recommended. Other oral competitors include Aubagio (fingolimod) and Gilenya (teriflunomide).

Invokana: New First-in-Class Type 2 Diabetes Treatment Approved

The first in a new class of type 2 diabetes drugs has been FDA-approved -- Invokana (canagliflozin) is an oral tablet indicated to improve blood sugar control in conjunction with diet and exercise in patients with type 2 diabetes. Invokana is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose (sugar) by the kidneys and increases glucose excretion in the urine. An improvement in hemoglobin A1c and fasting blood sugar levels in trials of more than 10,000 patients secured FDA approval. The FDA is requiring five post-approval drug studies from Janssen to assess safety outcomes.

Quartette Extended Regimen Birth Control Pills Approved by FDA

Women may frequently stop extended regimens of oral birth control due to breakthrough bleeding (BTB). Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) is Teva’s next generation of extended regimen oral contraceptives designed to minimize BTB between scheduled periods and increase adherence. Quartette features a unique 91-day oral regimen, whereby the dose of estrogen increases at three points over the first 84 days; this is followed by seven days of ethinyl estradiol. Quartette results in four short and light periods a year with a reduction in BTB over time. Other extended-release birth controls include Seasonique and Jolessa.

FDA Approves TOBI Podhaler

Cystic fibrosis (CF) patients often have chronic bacterial lung infections due to mucus buildup. The U.S. Food and Drug Administration has approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections. TOBI Podhaler is a handheld inhaler that contains tobramycin dry powder, an antibiotic. In clinical trials, 95 patients age 6 years or older were randomly assigned to receive TOBI Podhaler or a placebo. Patients treated with TOBI Podhaler experienced a statistically significant increase in lung function compared to the placebo group.

FDA Approves Lymphoseek to Map Lymph Nodes in Cancer

The U.S. Food and Drug Administration (FDA) has approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Lymphoseek is an imaging drug that helps locate lymph nodes; it is not a cancer imaging drug. Lymphoseek is the first new agent for lymph node mapping to be approved in more than 30 years. Other FDA-approved drugs used for lymph node mapping include sulfur colloid (1974) and isosulfan blue (1981).

Posted: March 2013