Amgen issued the following announcement on Oct. 27.
Amgen (NASDAQ:AMGN) today announced that it has completed trial design discussions through two Complex Innovative Trial Designs (CID) Pilot Program meetings with the U.S. Food and Drug Administration (FDA) for its planned Phase 2 efficacy and safety trial for efavaleukin alfa (formerly known as AMG 592), an investigational candidate for Systemic Lupus Erythematosus (SLE) treatment. The CID Pilot Program aims to modernize drug development, improve efficiency, and promote innovation. The efavaleukin alfa participation in the CID Pilot Program is based on an innovative adaptive clinical trial design developed to foster the acceleration of a potential therapeutic option that could benefit patients living with SLE.
"Systemic Lupus Erythematosus is an area with significant need for new therapies for those living with the condition, but one that has been challenging to address given the complexity of this autoimmune disease," said Rob Lenz, M.D., Ph.D., senior vice president, Global Development at Amgen. "Our partnership with the FDA on the CID Pilot Program should drive the development of a new treatment for lupus to address unmet need for patients."
"Amgen welcomes the opportunity to partner with the FDA through participation in the CID Pilot Program, which intends to advocate innovative clinical trial designs, as well as provide the FDA an opportunity to communicate these advances publicly," said Steven Galson, M.D., senior vice president, Global Regulatory Affairs and Strategy at Amgen. "We appreciate the FDA's efforts, significant contributions and feedback provided throughout the Pilot process."
The CID Pilot Program fulfills a performance goal agreed to under the Prescription Drug User Fee Act (PDUFA) VI, aiming to facilitate and advance the use of novel clinical trial designs that support the development and regulatory review of new therapeutics. Designs under the CID umbrella include, but are not limited to, complex adaptive, Bayesian, and other novel clinical trial designs which often require simulations to determine the statistical properties of the trial. The FDA considers several eligibility factors when selecting qualifying programs, including the level of innovation of the trial design, and the therapeutic need.
About Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that can impact multiple organ systems leading to fatigue, kidney failure, arthritis, rash and cardiovascular disease. While SLE disease activity is variable, most patients continue to experience periods of increased symptoms or flares which are associated with permanent organ damage and is associated with increased risk of death due to cardiovascular disease, infection and renal disease. Current treatments for SLE aim to control the symptoms by suppressing the immune response.
Efavaleukin alfa
Efavaleukin alfa is an IL-2 mutein Fc fusion protein. It is being investigated for the treatment of inflammatory diseases, including Systemic Lupus Erythematosus.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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