Expanded use of 9-valent HPV vaccine approved
The FDA approved an expanded use of the human papillomavirus (HPV) 9-valent vaccine, Recombinant (Gardasil) to prevent cancers and diseases caused by the nine HPV types the vaccine covers in women and men ages 27 through 45 years. The HPV 9-valent vaccine, a product of Merck, was already approved for males and females ages 9 through 26 years.
The FDA's current approval for the expanded indication of the HPV 9-valent vaccine in men and women ages 27 through 45 years was based on effectiveness data in women ages 27 through 45 years, efficacy data from the HPV 9-valent vaccine in younger men (ages 16 through 26), and immunogenicity data from a clinical trial in which 150 men (ages 27 through 45) received a three-dose regimen of the vaccine over 6 months.
The most commonly reported adverse reactions included headache, injection site pain, swelling, and erythema.
New drug to treat influenza approved by FDA
The FDA approved baloxavir marboxil (Xofluza) for the treatment of acute uncomplicated influenza in patients 12 years and older who have been symptomatic for 48 hours or fewer. It is the first antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Baloxavir marboxil is taken as a single oral dose.
The safety and efficacy of baloxavir marboxil was demonstrated in two randomized controlled clinical trials of 1,832 patients, with participants assigned to receive either baloxavir marboxil, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms. In both trials, patients treated with baloxavir marboxil had a shorter time to alleviation of symptoms compared with patients who took the placebo.
Baloxavir marboxil is a product of Shionogi & Co., Ltd.
FDA approves new migraine prevention drug
Galcanezumab-gnlm (Emgality), Eli Lilly's calcitonin gene-related peptide antagonist, has been approved by the FDA for the prevention of migraine in adult patients. Galcanezumab-gnlm is a humanized monoclonal antibody available as a self-administered subcutaneous injection. Patients or caregivers may give the injection after proper training. The recommended dose is 240 mg once as a loading dose, administered in two consecutive injections of 120 mg each, followed by monthly injections at 120 mg.
Galcanezumab-gnlm was studied in three clinical trials that included more than 2,000 patients with episodic or chronic migraine, and was shown to be associated with significantly greater reductions in monthly migraine headache days than placebo. According to the manufacturer, patients with commercial insurance are candidates to receive the drug for free for up to 12 months as part of the company's patient support program.
Adverse reactions reported in clinical trials included injection site pain, erythema, and pruritus. Consult product labeling for prescribing information.
New indication for canagliflozin to reduce risk of major CV events
The FDA approved an expanded indication for canagliflozin (Invokana) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes mellitus (T2DM) who have established cardiovascular disease (CVD). Canagliflozin, a sodium-glucose cotransporter type 2 (SGLT2) inhibitor is indicated to reduce risk of myocardial infarction (MI), stroke, or death due to a CV cause, according to Janssen, the manufacturer of canagliflozin.
The new indication also applies to the fixed-dose combinations of canagliflozin/metformin (Invokamet) and canagliflozin/metformin extended-release (Invokamet XR).
The FDA based the expanded indication on the results of the CANVAS (CANagliflozin cardioVascular Assessment Study), which evaluated the effect of the SGLT2 inhibitor on CV risk in a broad population of over 10,000 adults with T2DM who have established CV disease or who are at risk for CVD with two or more risk factors. Treatment with canagliflozin (compared with placebo) with standard of care treatment reduced the combined risk of MI, stroke, and CV death by 14%.