Gardasil good for men, too
Executive SummaryMerck says it is on track to submit an sBLA by the end of the year for use of its Gardasil human papillomavirus vaccine to prevent external genital lesions caused by HPV types 6, 11, 16 and 18 in men. The firm released a Phase III study Nov. 13 that showed Gardasil prevented 90 percent of external genital lesions caused by those HPV types in men aged 16 to 26. The study also found the vaccine was 85.6 percent effective at reducing persistent infection. Gardasil is approved for preventing HPV-related cancers in women aged nine to 26. Thus far the firm has not been successful in its attempts to expand Gardasil's indication to older women (1"The Pink Sheet," Sept. 15, 2008, In Brief)
You may also be interested in...
Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News
The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
Stephen Hahn, the Trump administration’s nominee to lead the US FDA, has been approved by the Senate Health, Education, Labor and Pensions (HELP) Committee, with some “no votes” from Democratic senators in leadership positions, and is expected to be considered by the full Senate this week.