Two new drugs recently approved by the FDA
Two new drugs have recently been approved by the U.S. Food and Drug Administration.
Avycaz (ceftazidime-avibactam), is a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor.
“It is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection”, says Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Avycaz is the fifth approved antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP). This designation is given to antibacterial products to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. And as part of its QIDP designation, Avycaz was given priority review, which provides an expedited review of the drug’s application.
The FDA has also given approval for a long-term birth control option for women. Actavis and Medicines360 announced that the FDA has approved their levonorgestrel-releasing intrauterine system (Liletta) for the prevention of pregnancy for up to 3 years.
A plastic T-shaped intrauterine device (IUD) inserted in the uterus by a health care professional, Liletta works by slowly releasing levonorgestrel at an average of 15.6 mcg/day over a 3-year period.
“At Actavis, we are committed to developing alternative forms of contraceptive options,” said Actavis Executive Vice President David Nicholson, PhD, in a press release. “With the FDA’s approval of Liletta, we are pleased to offer women a novel IUD which provides three years of safe and effective contraception.”
The FDA based its nod on a clinical trial evaluating Liletta in 1751 women. The research team deemed the contraceptive system safe and effective in women regardless of age, parity, or body mass index, with the system achieving a 3-year efficacy rate of 99.45%. Of the trial participants who chose to discontinue the study early, 97% returned to menses within three months after the system’s removal. Additionally, in a group of women trying to conceive, 87% became pregnant within one year of removal, with some women conceiving as soon as 12 days after removal.
“This new hormonal IUD was proven more than 99% effective in the largest ever IUD trial conducted in the US. It offers a long-term, highly-effective yet reversible option to prevent pregnancy for many women regardless of whether or not they’ve had a child before,” said the study’s principal investigator and lead author, David L. Eisenberg, MD. “This long-acting reversible contraceptive is a desirable option for women looking to prevent pregnancy.”
Approximately 19% and 33% of trial participants treated with Liletta experienced amenorrhea within 1 year of treatment and after 3 years of treatment, respectively. As a result of the collaboration between Actavis and Medicines360, Liletta will be both commercially available and accessible at a lower cost at public health clinics enrolled in the 340B Drug Pricing Program.
“The FDA’s approval of Liletta marks an important milestone for women, providers, and the reproductive health community. Liletta was designed from the beginning to be accessible by women, regardless of socioeconomic status,” said Medicines360 COO Pamela Weir. “In the past, many barriers including expensive upfront costs or lack of insurance coverage have prevented women from obtaining IUDs.”
Actavis and Medicines360 plan to launch Liletta in the United States in the second quarter of 2015, according to a manufacturer press release.
Sources: U.S. Food and Drug Administration and Pharmacy Times