A new medication is now approved by the FDA for the treatment of hemophilia A, it’s called Adynovate and it’s made by Baxalta.
The U.S. Food and Drug Administration announced on Friday, Nov. 13 that it granted approval to Baxalta drug Adynovate for the treatment of patients with Hemophilia A. The Antihemophilic Factor and PEGylated drug was given the green light for affected individuals aged 12 years old and above.
The drug has been developed into a modified version such that it can last longer in the blood and possibly necessitate lesser frequency of administration compared to unmodified Antihemophilic Factor when injected to decrease bleeding episodes.
FDA approved the drug to be administered on an “as needed” basis to treat and control bleeding, as well as lessen bleeding frequencies among patients diagnosed with Hemophilia A.
The components of Adynovate include the complete range of Coagulation Factor VIII molecule connected with polyethylene glycol (PEGylated). The connection between these molecules is the secret to the long-lasting stay of the drug in the blood of patients.
A total of 137 adults and adolescent patients were involved in the clinical trial to test the safety and efficacy of Adynovate. The tests entailed comparisons of conventional preventive treatment modalities to on-demand or “as needed” therapy.