New FDA Specialty Approvals
✦ Sept. 16: The FDA expanded the use of Roche’s CINtec PLUS Cytology test to help clinicians determine which women who test positive for human papillomavirus (HPV) via cobas 6800/8800 Systems require further diagnostic procedures to prevent disease progression. The test can detect two biomarkers associated with HPV infections that are transforming and can, if left untreated, progress to cervical precancer or cancer. The FDA initially approved the test in March (RSP 4/20, p. 8). Visit https://bit.ly/32YFreW.
✦ Sept. 25: The FDA gave an additional indication to GlaxoSmithKline plc’s Nucala (mepolizumab) for the treatment of people at least 12 years old with hypereosinophilic syndrome (HES) for at least six months without an identifiable nonhematologic secondary cause. The agency says this is the first approval for people with HES in almost 14 years. The FDA gave the product priority review, as well as orphan drug and fast track designations for this use. The agency initially approved the medication in November 2015 (RSP 11/15, p. 6). Dosing for the newest indication is 300 mg as three separate 100 mg subcutaneous injections once every four weeks. Website Drugs.com lists the price of one 100 mg vial as $3,218.84. Visit www.nucala.com.