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Omegaven Receives FDA Approval

Tuesday, August 14, 2018   (0 Comments)
Posted by: Cathy Harrington
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Kathleen Gura, PharmD, and Mark Puder, MD, PhD


Prior to 2004, children with parenteral nutrition associated liver disease (PNALD) had few options when treating this life-threatening complication of prolonged parenteral nutrition (PN) use. The treatment options were to transition to full enteral nutrition, use soybean lipid restriction, or undergo a transplant, each with their own set of possible complications.


Based on the pioneering work of Mark Puder, MD, PhD, and Kathleen Gura, PharmD, at Boston Children’s Hospital, in September 2004 a new option became available when clinical studies utilizing the fish oil based lipid emulsion Omegaven® (Fresenius Kabi) to treat these children began. This alternative for infants and children with PNALD improved their ability to remain on PN, allowing their intestines to grow and adapt and potentially wean safely from PN. Evidence also suggests infants and children are in a better nutritional state to withstand the rigors of transplant, if needed.


Unfortunately, the fish oil based lipid emulsion was only available via compassionate use protocols and families often had to travel thousands of miles to a center that offered this therapy. To help families obtain this lipid emulsion, Boston Children’s Hospital shared their protocol and disseminated information through Oley’s website and newsletters. Over the years, presentations at regional and national meetings helped to further disseminate information. Despite these efforts, in many cases, it was a hardship for families to reach centers that provided this therapy.


On June 27, 2018, the FDA approved Omegaven® based on data collected from Boston Children’s Hospital, Texas Children’s, and UCLA Medical Center. It will soon become available for children in need. There will be a lag time from approval until it will no longer be a study drug (approximately two to three months), so anyone who currently needs it will continue to receive it only through a compassionate use protocol. In the interim, the manufacturer, Fresenius Kabi, will be approaching insurance providers and pharmacy benefit managers as well as pharmaceutical wholesalers to determine reimbursement and assure patient access to the product.


Oley will work continuously with regulatory agencies and ASPEN to improve access to those patients in need.


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This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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