Mirena approved for pregnancy prevention up to 7 years
Mirena (levonorgestrel-releasing intrauterine system) has received FDA approval for up to 7 years of pregnancy prevention. The intrauterine device was previously approved for up to 6 years.
Mirena contains 52 mg of levonorgestrel, which initially releases at a rate of 20 mcg/day. That decreases progressively to approximately 10 mcg/day after 5 years and 8 mcg/day after 7 years. By the end of the seventh year, Mirena should be removed and replaced at the time of removal with a new system if continued use is warranted.
Mirena is also indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who chose to use intrauterine contraception. For this indication, Mirena should be replaced after the end of the fifth year, if continued treatment of heavy menstrual bleeding is needed.
Mirena is a product of Bayer HealthCare Pharmaceuticals Inc.
FDA formally approves first COVID-19 vaccine
Pfizer-BioNTech's COVID-19 vaccine (Comirnaty) is the first COVID-19 vaccine to move beyond Emergency Use Authorization (EUA) status and be formally approved for the prevention of COVID-19 in individuals 16 years of age and older. Comirnaty continues to be available under the EUA, which includes immunization of individuals 12 to 15 years of age, the administration of a third dose in certain immunocompromised individuals, and a single booster dose in certain individuals.
The FDA approved Pfizer-BioNTech's COVID-19 vaccine under the EUA on December 11, 2020. For the new approval, the FDA evaluated updated data and information from the clinical trial that supported the EUA and included a longer duration of follow-up in a larger clinical trial population, as well as extensive preclinical and clinical data and information, details of the manufacturing process, vaccine testing and quality, and inspections of manufacturing sites. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19.
The FDA analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within 1 week of receiving the second dose. Safety was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo. More than half of the clinical trial participants were followed for safety outcomes for at least 4 months after the second dose. Overall, approximately 12,000 recipients had been followed for at least 6 months.
Pfizer-BioNTech committed to additional postmarketing studies, including a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
First drug approved for chronic kidney disease-associated pruritus
Korsuva (difelikefalin) injection was approved by the FDA as the first and only approved therapy for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The drug is a first-in-class kappa opioid receptor agonist that targets the body's peripheral nervous system and received priority review from the agency. Korsuva injection is not a federally controlled substance.
The approval was based on positive data from two pivotal phase 3 trials and data from 32 more clinical studies showing Korsuva produced substantial improvement in symptoms and meaningful relief for people suffering from severe and debilitating itch in patients undergoing hemodialysis. Korsuva was generally well tolerated.
Korsuva is a product of Vifor Pharma and Cara Therapeutics.