FDA Actions
January 1, 2015
The FDA has approved the first IV drug to treat influenza. Peramivir is a neuraminidase inhibitor similar to oseltamivir (Tamiflu) and zanamivir (Relenza). Peramivir is administered as a single 600 mg IV dose. The drug was approved on the strength of a single trial of nearly 300 patients with flu who received peramivir 600 mg, 300 mg, or placebo. If given within 48 hours of the onset of symptoms, the 600 mg dose alleviated flu symptoms 21 hours sooner than placebo, although efficacy could not be established in seriously ill patients requiring hospitalization. The most common side effect is diarrhea, although there was also a higher incidence of hallucinations and delirium in patients with flu. Peramivir is marked by BioCryst Pharmaceuticals as “Rapivab.”
The FDA has approved a new 9-valent HPV vaccine (Gardasil 9) for the prevention of human papillomavirus infections. The previous Gardasil vaccine protected against four strains of the virus. The new vaccine has the potential to prevent 90% of cervical, vulvar, vaginal, and anal cancers. The 9-valent vaccine is approved for females ages 9-26 and males ages 9-15. Gardasil 9 was approved based on a study of about 14,000 females in the target ages who received either Gardasil or Gardasil 9. The newer vaccine is 97% effective in preventing cervical, vulvar, and vaginal cancers caused by the additional HPV types not covered in the older vaccine, and was as effective as the older vaccine in protecting against the four shared HPV types. The vaccine is administered as three shots at zero, 2, and 6 months. Gardasil 9 is manufactured by Merck Sharp & Dohme Corp.
The FDA has approved liraglutide for the new indication of chronic weight management, in addition to a reduced-calorie diet and physical activity. The drug, which is a GLP-1 receptor agonist, is already approved for treatment of type 2 diabetes under the trade name Victoza, but at a lower dose. The drug was approved for weight loss based on clinical trials of about 4,800 obese and overweight patients, showing that patients given liraglutide lost between 3.7-5% of body weight depending on the clinical setting, with diabetic patients losing the least weight. The drug is given as a once a week subcutaneous injection. As with all drugs in this class, liraglutide comes with a boxed warning regarding an increased incidence of thyroid tumors seen in rodent studies. Serious side effects include pancreatitis, gallbladder disease, renal impairment, suicidal ideation, and elevated heart rate. Liraglutide is marketed Novo Nordisk as Saxenda.
The FDA has approved the fourth new antibacterial drug for 2014 with the approval of the combination drug ceftolozane/tazobactam. Ceftolozand is an antipseudomonal cephalosporin, while tazobactam is a beta-lactamase inhibitor. The combination is approved to treat complicated intra-abdominal infections and complicated urinary tract infections. In clinical trials, the combination (with metronidazole) was found to be non-inferior to meropenem for complicated abdominal infections, and noninferior to levofloxacin for complicated urinary tract infections. Ceftolozane/tazobactam is marketed by Cubist Pharmaceutical as Zerbaxa. The drug was approved as a Qualified Infectious Disease Product and given expedited review, qualifying the drug for an additional 5 years of marketing exclusivity.
Alcon Laboratories has received approval to market a new otic fluoroquinolone suspension for the treatment of acute otitis media. Finafloxacin otic suspension treats infections caused by Pseudomonas aeruginosa- and Staphylococcus aureus-causing infection of the outer ear and ear canal. Alcon will market finafloxacin otic as “Xtoro”overseas. It is not clear when Alcon plans on marketing the product in this country.
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