FDA approves two important drugs

By ACSH Staff — Jan 31, 2012
Sweet news for Type 2 diabetes patients: The FDA just announced the approval of Amylin Pharmaceuticals new drug, Bydureon. Instead of requiring daily injections, as an earlier form of the drug (Byetta) does, Bydureon is injected only once a week; it works to provide long-lasting glucose control and facilitate weight loss without the need for constant glucose monitoring.

Sweet news for Type 2 diabetes patients: The FDA just announced the approval of Amylin Pharmaceuticals new drug, Bydureon. Instead of requiring daily injections, as an earlier form of the drug (Byetta) does, Bydureon is injected only once a week; it works to provide long-lasting glucose control and facilitate weight loss without the need for constant glucose monitoring.

Initially rejected twice in 2010 due to safety concerns such as heart rhythm abnormalities, Bydureon finally received approval provided that Amylin conduct another clinical trial to assess whether the drug increases the risk of heart attack, cardiovascular problems, thyroid cancer, or pancreatitis. ACSH's Dr. Gilbert Ross, however, believes these health concerns arose out of excessive precaution and is optimistic that the much more convenient weekly schedule and relatively economical cost will provide many diabetics with a less burdensome treatment option.

Speaking of new drug approvals, the FDA also gave the green light to Genentech s newest skin cancer drug, Erivedge. The once-a-day pill will be used to treat basal cell carcinoma, the most common type of skin cancer, in patients with extensive local disease who are not eligible for surgery or radiation; it will also be used in rare cases in which the cancer has metastasized. Dr. Ross was excited to learn of Erivedge s approval, since it is the first and only drug available to treat advanced basal cell carcinoma.