Gardasil 9 for prevention of head and neck cancer
Gardasil 9 (Human Papillomavirus [HPV] 9-valent Vaccine, Recombinant) was approved to prevent head and neck cancer. It is indicated in females ages 9 through 45 for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.
The vaccine is indicated in males ages 9 through 45 for the prevention of anal, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.
The vaccine is a product of Merck.
Canagliflozin boxed warning for leg and foot amputations removed
Based on new data, the FDA removed the boxed warning on the prescribing information for the type 2 diabetes mellitus (T2DM) drug canagliflozin (Invokana, Invokamet, Invokamet XR) concerning amputation risk. The warning was added to canagliflozin labeling in 2017 because earlier data suggested the risk of amputations was serious in relation to the potential benefit of taking the medication. However, subsequent FDA reviews of new clinical trial data showed additional benefits, which led to additional approved uses for canagliflozin, including reducing the risk of major adverse cardiovascular (CV) events in patients with T2DM and known CV disease, and reducing the risk of end-stage kidney disease, worsening of kidney function, CV death, and hospitalization for heart failure in certain patients with T2DM and diabetic kidney disease.
These heart- and kidney-related effects demonstrate significantly enhanced benefits of canagliflozin. Data also suggest that the risk of amputation, while still increased, is lower than previously described, especially when appropriately monitored. The FDA notes that the amputation risk associated with canagliflozin remains and is still described in the warnings and precautions section of the labeling.
Rapid-acting insulin approved for type 1 and type 2 diabetes mellitus
The FDA approved Eli Lilly's rapid-acting insulin lispro-aabc injection, 100 and 200 units/mL (Lyumjev) for the treatment of adults with type 1 (T1DM) and T2DM. The new formulation of insulin lispro was developed to speed insulin absorption into the bloodstream and reduce A1C levels. The product is approved only for use as part of a multiple daily injection regimen and is not indicated for use in insulin pumps.
Two phase 3 randomized controlled trials comparing Lyumjev and Humalog in adults with T1DM and T2DM, respectively, met the primary end point of noninferior A1C reduction from baseline compared with Humalog at 26 weeks. The product also demonstrated superior reduction in blood glucose spikes at both 1 hour and 2 hours after a test meal compared with Humalog. Lyumjev and Humalog have similar safety and tolerability profiles. Hypoglycemia is the most common adverse reaction associated with the drug.
Mirena approved for 6 years of pregnancy prevention
The FDA approved the levonorgestrel-releasing intrauterine system (Mirena) for up to 6 years of pregnancy prevention. Previously, the intrauterine device (IUD) was indicated for contraception for up to 5 years.
Approval was based on data evaluating the efficacy of the IUD during extended use beyond 5 years. The pregnancy rate, calculated as the Pearl Index, at the end of the 6th year of use was 0.35 with a 95% upper confidence limit of 1.95 based on the 1 pregnancy that occurred during year 6 and within 7 days after IUD removal or expulsion.