European and German authorities approve octagam® 10% for adults with dermatomyositis

Octapharma announced today that octagam® 10%, a human plasma-derived intravenous immunoglobulin (IVIg), has recently been granted approval in the European Union (EU) as an immunomodulatory therapy for adults with dermatomyositis. Following the EU approval, octagam 10%® received national approval in Germany on May 11, 2021, with approval in other European member states expected soon. 

Octagam® 10% is the first treatment to be approved for dermatomyositis in the EU and is indicated for use in adults with active dermatomyositis treated with immunosuppressive drugs, including corticosteroids, or with intolerance or contraindications to those drugs. The decision to approve octagam® 10% was based on the results from the phase III ProDERM study (NCT02728752), the first large randomised controlled trial of IVIg for dermatomyositis.

“The positive results from the ProDERM study demonstrate the value of octagam® 10% as a treatment option for dermatomyositis patients,” commented Nobert Müller, Board Member at Octapharma. “This approval is a major step towards enabling patients across Europe to benefit from this efficacious treatment."

Dermatomyositis is a rare, idiopathic autoimmune disorder, with patients commonly suffering from skin rashes, chronic muscle inflammation and progressive muscle weakness. Corticosteroids or other immunosuppressive drugs are often used for treatment; however, these therapies are not approved for use in patients with dermatomyositis. Furthermore, some patients experience adverse events with these treatments, or do not respond to therapy1. The premature mortality gap in dermatomyositis has persisted in recent years. DM patients have over three-fold higher risk of mortality compared with matched general population2.

The ProDERM study was a double-blind, placebo-controlled randomised trial that investigated the efficacy and safety of octagam® 10% in adults with dermatomyositis. A significantly higher proportion of the patients randomised to octagam® 10% showed a response to treatment compared with the placebo group in the initial 16-week period (79% vs 44%, p=0.0008).

Patients eligible at the end of the first period (N=91) could continue in the following 24 weeks open label extension period with all patients receiving octagam® 10%. At the end of the extension phase, patients previously treated with octagam 10% maintained their improvement and patients initially randomised to placebo improved to a comparable level after switching to octagam® 10%. Octagam® 10% was generally well tolerated throughout the study.

The final results of the ProDERM study will be presented on June 3 by Dr. Rohit Aggarwal, professor of medicine from the University of Pittsburgh, at the European Alliance of Associations for Rheumatology (EULAR) Virtual European Congress of Rheumatology.

“Patients with dermatomyositis have had few effective treatment options until now and relied primarily on long-term corticosteroid use,” said Dr. Aggarwal, who was a member of the Steering Committee for the ProDERM study. “This approval is a historic moment for patients with dermatomyositis and will offer a highly efficacious alternative to corticosteroid use, with the potential for fewer side effects.”

“The European approval for octagam® 10% marks a significant milestone in improving the lives of adults with dermatomyositis,” said Olaf Walter, Board Member at Octapharma. “We are dedicated to providing safe and effective treatment options and are proud to be able to offer a treatment with clear clinical benefits for these patients.”

About the ProDERM study

The Progress in DERMatomyositis study (ProDERM, NCT02728752) was an international, multi-centre, double-blind, randomised, placebo-controlled phase III clinical trial that investigated the efficacy and safety of octagam® 10% in patients with dermatomyositis. The ProDERM study enrolled 95 patients from 36 sites in 10 countries.

About octagam® 10%

Octagam® 10% is a ready to use, liquid preparation of highly purified human immunoglobulin for intravenous administration. Octagam® 10% is approved for idiopathic thrombocytopenic purpura in the US, EU and Canada. It is also approved for use in treatment of primary immunodeficiency, secondary immunodeficiencies and Guillain Barré syndrome in the EU and Canada and for dermatomyositis, CIDP and MMN in the EU.

 About dermatomyositis

Dermatomyositis is a rare immune-mediated inflammatory myositis characterised by skin rashes on the eyelids, chest, and joints of the hands as well as proximal muscle weakness secondary to chronic skin and muscle inflammation, respectively3. Until recently, there were no therapies approved by the US or European regulatory authorities for the treatment of dermatomyositis, based on adequate randomized controlled trials, despite significant association with morbidity and mortality.

 About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs more than 9,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology, and Critical Care.

Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, and operates more than 160 plasma donation centres across Europe and the US.

References

1.     Cordeiro AC, Isenberg DA. Treatment of inflammatory myopathies. Postgrad Med J 2006; 82:417–24.

2.     D'Silva, K. M. et al. Persistent premature mortality gap in dermatomyositis and polymyositis: a United Kingdom general population-based cohort study. Rheumatology 2020; DOI: 10.1093

3.     Findlay AR, et al. An overview of polymyositis and dermatomyositis. Muscle Nerve 2015; 51:638–56.

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