FDA Gives Fast Track Approval to Cannabis Medicine for Newborns

FDA Gives Fast Track Approval to Cannabis Medicine for Newborns

GW Pharmaceuticals, a biopharmaceutical company with a focus on cannabinoid-based medicines, has received fast track approval from the U.S. Food and Drug Administration (FDA) for a medicine designed to treat newborns deprived of oxygen during childbirth, which can lead to brain damage and death.

The FDA gave approval to an intravenous form of cannabidiol (CBD) to treat Neonatal Hypoxic-Ischemic Encephalopathy (NHIE), which is a form of acute or sub-acute brain injury caused by asphyxia that occurs during birth. The medicine has already received approval from the European Medicines Agency to treat perinatal asphyxia, an alternate term to describe the same condition as NHIE.

“GW believes that cannabinoids may have a potentially important role in the treatment of high need paediatric neurologic conditions”, says Justin Gover, GW Pharmaceuticals CEO, said. “As a result, we have developed a proprietary intravenous CBD formulation specifically for use in this most vulnerable of patient populations, newborn infants with NHIE.”

Now that they’ve received Fast Track designation, GW Pharmaceuticals is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval to get important new drugs to the patient earlier.

Currently there are no approved medicines in Europe or the U.S. designed specifically to treat NHIE..

– TheJointBlog