New indication: Hydroxyprogesterone caproate injection was approved by FDA in February to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of at least 1 spontaneous preterm birth.
A synthetic progestin, hydroxyprogesterone caproate intramuscular injection to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of at least 1 spontaneous preterm birth
Hydroxyprogesterone caproate injection was approved on February 4 under FDA's accelerated approval regulations that allow promising drugs to be marketed in the United States based on surrogate end point data that likely predicts an important clinical benefit. Hydroxyprogesterone caproate injection is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Efficacy. Efficacy data supporting hydroxyprogesterone caproate injection's ability to reduce the risk of spontaneous preterm birth is derived from a multicenter, randomized, double-blind, placebo-controlled clinical trial. In this trial, 463 pregnant women aged 16 to 43 years who were pregnant with a single fetus and had a history of a prior spontaneous preterm birth (<37 weeks gestation) were enrolled. Among women treated with Makena (n=310), 37% delivered preterm as compared with 55% of women in the placebo group (n=153) (difference for delivering prior to 37 weeks, -17.8%, 95% CI, -28.0% to -7.4%; <35 weeks, -9.4%, 95% CI, -19.0% to -0.4%; and <32 weeks, -7.7%, 95% CI, -16.1% to -0.3%). Despite these benefits, an overall survival benefit was not demonstrated in this trial due to a higher rate of miscarriages and stillbirths in the Makena group compared to placebo group. In a follow-up study evaluating children born to the above studied women (n=287, 79.9% of eligible infants), the proportion of children (aged 2-5 years) diagnosed with developmental delay [using the Ages & Stages Questionnaire (ASQ)] was similar between groups.
Dosing. Hydroxyprogesterone caproate injection is administered intramuscularly beginning at 16 weeks/0 days to 20 weeks/6 days of gestation at a dose of 250 mg (1 mL) once weekly and continued until week 37 of gestation or delivery, whichever occurs first. Hydroxyprogesterone caproate injection is contraindicated in patients with current or a history of thromboembolic disorders, known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions, undiagnosed abnormal vaginal bleeding unrelated to pregnancy, cholestatic jaundice of pregnancy, liver tumors or active liver disease, or uncontrolled hypertension.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1st 2024Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
Read More
ICER Gives Cell Therapy for Post-Transplant Complications High Rating
Published: October 31st 2024 | Updated: October 31st 2024ICER has given tabelecleucel a rating of A, indicating the T cell therapy for Epstein-Barr virus related post-transplant lymphoproliferative disease has a high certainty of substantial net health benefit and would be cost-effective if priced between $143,900 and $273,700.
Read More