- Medexus Pharmaceuticals Inc. (MDP) is investigating IXINITY as a treatment for patients under the age of 12 with hemophilia B
- The company hopes to expand its product label to include hemophilia B patients under the age of 12
- Medexus has enrolled its final patient in the phase 4 trial, which is expected to be completed in June 2022
- Medexus Pharmaceuticals is a leading specialty pharmaceutical company with a strong North American commercial platform
- Medexus Pharmaceuticals Inc. (MDP) is currently down 1.90 per cent, trading at $4.12 per share
Medexus Pharmaceuticals Inc. (MDP) is investigating IXINITY as a treatment for patients under the age of 12 with hemophilia B.
Hemophilia B is a hereditary bleeding disorder that is caused by a deficiency of the clotting factor IX. Medexus has developed IXINITY as an intravenous IX therapeutic for pediatric patients.
In this phase 4 clinical trial, the company hopes “to expand the IXINITY product label to include the U.S. pediatric population below 12 years of age,” said Medexus director of regulatory affairs Khaled Mohamed.
According to the World Federation of Hemophilia’s 2017 report, approximately one in three patients treated for hemophilia B in the United States are 12 years old or younger.
“We believe this could prove to be a vital, additional therapy option to the pediatric population and look forward to submitting the full data set to FDA by end of 2022,” added Mr. Mohamed.
Medexus has enrolled its final patient in the phase 4 trial, which is expected to be completed in June 2022.
“The hemophilia B market in the U.S. alone is estimated to be in excess of US$1 billion,” said Medexus CEO Ken d’Entremont.
“If approved,” he added, “we expect to be well positioned to commercialize quickly with the infrastructure we already have in place for the adult market.”
Medexus Pharmaceuticals is a leading specialty pharmaceutical company with a strong North American commercial platform.
The company’s vision is to provide the best healthcare products to healthcare professionals and patients.
Medexus Pharmaceuticals Inc. (MDP) is currently down 1.90 per cent, trading at $4.12 per share as of 12:34 pm ET.