New Drugs
The following are some of the recent approvals announced by the US Food and Drug Administration (FDA):
- Lenvima (lenvatinib; Eisai Inc) was approved to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvima received priority review and orphan product designation.
- Dutrebis (lamivudine, raltegravir; Merck & Co, Inc) was approved for use in combination with other antiretroviral products for adults and pediatric patients (≥6 years, ≥30 kg). According to the manufacturer, Dutrebis will not be made commercially available at this time.
- Ibrance (palbociclib; Pfizer, Inc) was granted accelerated approval for the treatment of patients with metastatic breast cancer. Ibrance received breakthrough therapy designation because it may offer substantial improvement over available therapies.
- Lucentis (ranibizumab injection; Genentech, Inc) was approved for expanded use to treat diabetic retinopathy in patients with diabetic macular edema.
- Vyvanse (lisdexamfetamine dimesylate; Shire US, Inc) was approved for expanded use to treat adult patients with binge- eating disorders. This is the first FDA-approved medication for this condition.
New Generic
The first generic version of Nexium (esomeprazole magnesium delayed-release capsules; Teva Pharmaceutical Industries Ltd) has been approved by the FDA for the treatment of adults and children aged ≥1 years with gastroesophageal reflux disease. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.In addition, esomeprazole capsules were also approved to reduce the risk of gastric ulcers associated with the use of nonsteroidal anti-inflammatory drugs, and to treat Helicobacter pylori infection with certain antibiotics, as well as conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.
The FDA announcement also indicated that the generic capsules will be dispensed with patient Medication Guides providing important information about the uses and risks of the medication. In particular, the most serious risks associated with esomeprazole included severe diarrhea and a warning that people taking multiple daily proton pump inhibitors for a long period of time may have an increased risk for bone fractures.
Headaches, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation, and dry mouth were the most common side effects reported by patients taking Nexium in clinical trials.
Sources: US Food and Drug Administration. New and generic drug approvals. www.fda. gov/Drugs/NewsEvents/ucm130961.htm. Last updated February 19, 2015. Accessed February 20, 2015; US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm. Updated February 20, 2015. Accessed February 20, 2015.