The FDA approved AstraZeneca’s Iressa as a first-line treatment for patients with metastatic non-small cell lung cancer. The drug, which was granted orphan-drug status last August, is a targeted therapy. AstraZeneca partnered with Qiagen to develop an FDA-approved companion diagnostic test that is used to determine whether the patient has an epidermal growth factor receptor genetic mutation, which would make him or her eligible for treatment. The drug was first approved by the FDA in 2003 but has been off the market in the US since 2005 after the agency updated and limited Iressa’s indication.
Mylan and Dr. Reddy’s Laboratories announced the launches of generic versions of Actavis’s Namenda, which is used to treat Alzheimer’s disease and dementia. The New York State Attorney General last year sued Actavis, alleging that the company’s introduction of a newer formulation of Namenda violated antitrust laws. Namenda’s patent expired in October.
The recent wave of consolidation in the health insurance industry may signal more pressure on drug spending, according to a report from Moody’s Investors Service. Cancer drugs, in particular, will be one area of focus for insurers, The Wall Street Journal‘s Pharmalot blog reported, especially after short-term integration plans are addressed. Aetna recently announced it plans to spend $37 billion to buy Humana, and Centene announced a $6.3-billion bid for Health Net.
The European Medicines Agency said it will review HPV vaccines to better understand if they are linked to two rare conditions, The Associated Press reported. The two conditions are complex regional pain syndrome and postural orthostatic tachycardia syndrome, which cause the heart rate to jump after sitting or standing.
Medical experts are stressing caution around the use of nonaspirin, nonsteroidal anti-inflammatory drugs after the FDA last week said the painkillers had higher risks of heart attack and stroke than previously believed, according to The New York Times. The over-the-counter drugs, which are commonly called Nsaids, include Advil, Motrin IB, Aleve and Celebrex. They do not include aspirin. The FDA will ask drugmakers to update labels for these treatments.