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ImmuPharma partner looks to streamline phase III approval process for lupus drug

The special assessment protocol is a process that decides on the design and size of the study that will both meet the scientific and regulatory requirements and supports marketing approval for new drugs such as Lupuzor

ImmuPharma PLC -

ImmuPharma PLC (LON:IMM, FRA: 25I) has said its licensing partner has submitted a special protocol assessment (SPA) request to the US regulators ahead of a phase III clinical trial of its lupus drug.

The SPA is a process by which the US Food & Drug Administration and Avion Pharmaceuticals will decide on the design and size of the study that will both meet the scientific and regulatory requirements and supports marketing approval for Lupuzor.

The review period for an SPA request is up to 45 days, said ImmuPharma, which has been working with Avion to finalise a new optimised international protocol.

Poorly treated

Lupus is what’s called a systemic autoimmune disease that occurs when the body's immune system attacks its own tissues and organs.

Inflammation caused by lupus can affect many different systems, including joints, skin, kidneys, blood cells, brain, heart and lungs.

While, thankfully, it is rare, Lupus’ symptoms are painful and sometimes fatal.

The condition is poorly treated with only one bespoke drug for the condition – Benlysta, developed by GlaxoSmithKline. AstraZeneca is expected to add a second medication when it brings anifrolumab to the market next year.

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