This is the first specific FDA approval for treatment with cost recovery for this disorder. This first approval for treatment with cost recovery means that patients reimburse the cost of the drug, allowing the company to recover a portion of the research, development and manufacturing costs associated with its development to date.
Patients also absorb the cost of twice weekly drug infusion and lab tests.
The treatment program in the U.S. initially will be directed towards the most severely disabled patients who are expected to be treated for 24 weeks followed by medical evaluation and reassessment. Simultaneously, sales of Ampligen have also begun in Montreal and Vancouver under the Canadian Emergency Drug Release Program. The approval in Canada covers patients in all stages of the disease, where the CFS patient population is estimated at more than 100,000. As in the United States, patients on the treatment may also absorb additional costs associated with drug infusion and medical oversight. All sites have received or are awaiting confirmation from their local Review Boards or Ethics Committees that they may begin treating patients with Ampligen.