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H.P. Acthar Gel (repository corticotrophin injection) was approved for marketing in 1952. Since that time Acthar gel has shown to produce positive therapeutic outcomes in disease states such as infantile spasms, nephrotic syndrome, and multiple sclerosis.
Effectiveness of H.P. Acthar Gel (ACTH) for treatment of infantile spasms was shown in a single blinded clinical trial in which patients received either a 2 week course of treatment with H.P. Acthar Gel or prednisone. The study compared the number of patients in each group who were treatment responders. Thirteen of 15 patients (86.7%) responded to Acthar Gel as compared to 4 of 14 patients (28.6%) given prednisone. Afterwards the prednisone nonresponders were given the choice to receive H.P. Acthar Gel treatment. Seven of 8 patients (87.5%) responded to H.P Acthar Gel after not responding to prednisone. Studies have also shown that patients with nephrotic syndrome have had successful outcomes with Acthar Gel after failing other therapies. The Bomback, et al study demonstrated that ACTH gel produced remission rates approaching 80%. Also the Rauen, et al study concluded ACTH treatment produced a lasting remission with few side effects. Ponticelli, et al performed a study which compared the combination therapy of methylprednisolone with a cytotoxic agent and monotherapy of ACTH. The findings showed monotherapy ACTH was as effective for nephrotic patients as the combination of methylprednisolone and a cytotoxic agent.
Filippini, et al produced a study of the use of H.P. Acthar Gel for multiple sclerosis in two randomized, double-blind trials. ACTH showed a protective effect against progression and stabilization of the disease. Thompson, et al’s trial showed marked improvement in patients with acute relapse of MS after the use of ACTH. The study from Hauser, et al determined that combination therapy with cyclophosphamide and ACTH stabilized patients’ progressive MS.
Approved indications that are not supported by the clinical literature have been excluded from prior approval criteria.