Le Lézard
Classified in: Health, Science and technology
Subjects: CHI, FDA, DEI

FDA Approves First Oral Blood Thinning Medication for Children


SILVER SPRING, Md., June 21, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism.

In addition, Pradaxa was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to prevent recurrent clots in patients eight years and older who completed treatment for their first venous thromboembolism.

Pradaxa is the first FDA-approved blood thinning medication that children can take by mouth; the only other approved blood thinning medication for children is given by injection. Pradaxa was originally approved in 2010 to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

"The FDA is committed to helping our youngest patients with serious medical conditions have treatments that are relatively easy to take," said Ann Farrell, M.D., director of the Division of Non-Malignant Hematology in the FDA's Center for Drug Evaluation and Research. "With today's approval of Pradaxa, pediatric patients have another therapeutic option to treat and prevent potentially deadly blood clots."

Blood clots can be a serious problem in children as well as adults. Children are most at risk for blood clots if they have cancer, congenital heart disease, a central venous catheter, or are admitted to an intensive care unit. Venous thromboembolism can lead to complications, including swelling and discomfort near the clot, chest pain, lung damage, and even death. 

The safety and efficacy of Pradaxa for treating blood clots in patients younger than 18 was evaluated in one study of 267 pediatric patients. In this open-label study, patients were randomly assigned to receive either Pradaxa or standard of care. The study compared the two groups for the number of patients who met the composite endpoint (a combination of multiple clinical endpoints), which meant that they had not died from a blood clot, their blood clots had completely resolved, and they had no additional blood clots. Results showed that 81 (45.8%) of the 177 people taking Pradaxa met the composite endpoint compared to 38 (42.2%) of the 90 patients who received standard of care.

The safety of Pradaxa to prevent recurrent blood clots in the same pediatric population was evaluated in an open-label, single-arm study in 214 patients with a history of blood clots. The primary endpoints of the study were recurrence of blood clots, major and minor bleeding events, and death (both overall and related to blood clots). The safety of Pradaxa with long-term use was similar to the previously discussed study. Recurrence of blood clots occurred in three patients (1.4%), which was comparable to prior standard-of-care treatments.

The most common side effects of Pradaxa include digestive system symptoms and bleeding. Pradaxa can cause serious and fatal bleeding. Pradaxa is not recommended for patients with bioprosthetic heart valves or triple-positive antiphospholipid syndrome. Pradaxa has a boxed warning cautioning that early treatment discontinuation may increase the risk of blood clots and that blood accumulation within parts of the spinal cord (spinal or epidural hematomas) in patients undergoing spinal procedures may cause serious side effects.

Pradaxa received a priority review designation for this indication.

The FDA granted the approval of Pradaxa to Boehringer Ingelheim Pharmaceuticals, Inc.

Media Contact: Chanapa Tantibanchachai, 202-384-2219
Consumer Inquiries: Email or 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

 

SOURCE U.S. Food and Drug Administration


These press releases may also interest you

at 06:05
Merck , known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the...

at 06:02
Following the successful and well-received Allograft line, Neoss is excited to announce the addition of NeoGenix XPtm this autumn to our existing product portfolio. NeoGenix XPtm is a safe and clinically proven natural bone substitute, that closer...

at 06:00
Being vaccinated during childhood with the BCG (Bacille Calmette-Guérin) vaccine against tuberculosis is not a long-term protective factor against COVID-19, despite what was thought at the beginning of the pandemic. A team of scientists from the...

at 06:00
The healthcare artificial intelligence (AI) market is expected to surpass USD 34.5 billion by 2027, as reported in a research study by Global Market Insights Inc. Artificial intelligence has revolutionized the field of healthcare by designing...

at 06:00
The light therapy market size is set to grow by USD 201.87 million from 2021 to 2025, according to Technavio. The report offers a detailed analysis of the market in optimistic, probable, and pessimistic forecast scenarios....

at 06:00
10x Genomics , a life sciences leader focused on mastering biology to advance human health, today marked a major Asia Pacific (APAC) expansion with the grand opening celebration of its Singapore manufacturing facility and commercial hub. The...



News published on 21 june 2021 at 16:00 and distributed by: