Skip to Content

Weekly Drug News Round Up - June 18, 2014

Lymphoseek Indications Expanded to Diagnose Cancer Severity

New indication will allow for more limited lymph node surgery in patients with sentinel nodes negative for cancer Read More...

The U.S. Food and Drug Administration has approved a second indication for the radioactive diagnostic imaging agent Lymphoseek (technetium Tc 99m tilmanocept). Navidea’s Lymphoseek is now approved to help determine the extent of spread of squamous cell carcinoma in the head and neck region. Lymphoseek was originally approved to help doctors locate lymph nodes in patients with cancers such as breast cancer and melanoma that are undergoing surgery and may need lymph node removal. For this new indication, Lymphoseek’s safety and effectiveness were established in a clinical trial of 85 patients with squamous cell carcinoma of the lip, oral cavity, and skin.

Azilect for Parkinson’s Disease Approved for Use with Dopamine Agonists

Symptoms of Parkinson's disease include tremors, muscle stiffness, and a shuffling gait, among other movement problems Read More...

The U.S. Food and Drug Administration (FDA) has expanded the indications for Teva’s Azilect (rasagiline tablets) in Parkinson’s disease from use alone or with levodopa to now also include combined use with dopamine agonists (DA). Azilect is a monoamine oxidase-B (MAO-B) inhibitor and works by increasing the levels of dopamine in the brain. Clinical studies supporting the approval demonstrated Azilect provides a clinical benefit by significantly improving total Unified Parkinson’s Disease Rating Scale (UPDRS) scores compared to placebo in patients on DA monotherapy, while demonstrating tolerability. As many as one million Americans live with Parkinson's disease, according to the Parkinson’s Disease Foundation.

Mylan Launches Generic Actonel in U.S.

In 2010, worldwide sales of Actonel were roughly $1.6 billion Read More...

Warner Chillcott’s osteoporosis brand Actonel (risedronate) has been launched in generic form in the U.S. This past week, Mylan announced the launch of the risedronate 150 mg tablets for the treatment and prevention of osteoporosis in postmenopausal women. Risedronate is a bisphosphonate that alters the cycle of bone formation and breakdown in the body to help increase bone mass and prevent bone fractures. Risedronate is also used to treat Paget's disease of the bone. According to FDA, other generic manufacturers will be marketing risedronate, including Teva and Apotex.

Levodopa Still the Best Initial Treatment for Parkinson’s Disease

Newer drugs are more likely to cause side effects such as nausea, hallucinations, swelling and sleep problems Read More…

Levodopa, a dopamine drug used for decades in Parkinson’s disease, has been found to outperform newer medications for the treatment of patients newly diagnosed with Parkinson's. The research, published last week in The Lancet, shows that levodopa offered patients better mobility and a higher quality of life than the two main alternatives -- drugs called dopamine agonists (such as Requip) and monoamine oxidase type B (MAO-B) inhibitors (such as Eldepryl). Overall, researchers noted that when the short- and long-term benefits, side effects, quality of life, and costs are considered, the older drug levodopa is still the best initial treatment strategy for most patients.

Crohn's, Colitis Drugs Not Linked to Short-Term Cancer Risk: Study

TNF-a helps to protect the body against cancer, raising concerns that blocking it could increase the risk of cancer Read More…

As reported today in the Journal of the American Medical Association (JAMA), tumor necrosis factor alpha (TNF-a) antagonists, or TNF blockers, a popular class of drugs used to treat ulcerative colitis and Crohn’s disease, are not linked to a short-term increased risk for cancer. The investigators found that cancer occurred in nearly seven percent of patients who had never taken TNF blockers, compared with fewer than two percent of patients who had been treated with the drugs. Studies lasted only 4 years, so longer-term effects were not reported. Examples of anti-TNF-a drugs include: adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi) and infliximab (Remicade).