Research & Development
Amgen Completes Discussions for Systemic Lupus Erythematosus Adaptive Clinical Trial In The FDA Complex Innovative Trial Designs Pilot Program
28 October 2020 - - US-based biotechnology company Amgen (NASDAQ: AMGN) has completed trial design discussions through two Complex Innovative Trial Designs Pilot Program meetings with the US 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 treatment, the company said.

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.

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.

Systemic Lupus Erythematosus 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 is an IL-2 mutein Fc fusion protein. It is being investigated for the treatment of inflammatory diseases, including Systemic Lupus Erythematosus.


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