Pfizer has received orphan drug designation from the US Food and Drug Administration (FDA) for the autoimmune candidate GL-2045.

FDA has granted status for GL-2045, which is a recombinant intravenous immune globulin (IVIG)-mimetic, to treat chronic inflammatory demyelinating polyneuropathy (CIDP).

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CIDP is a rare neurological disorder that is characterised by progressive weakness and impaired sensory function in the legs and arms.

“This orphan drug designation is important in that it provides numerous incentives to develop GL-2045 to address an unmet need in CIDP, a rare neurological disorder.”

Gliknik CEO David Block said: “This orphan drug designation is important in that it provides numerous incentives to develop GL-2045 to address an unmet need in CIDP, a rare neurological disorder.”

In September 2013, Pfizer signed an exclusive worldwide licencing agreement with Gliknik for GL-2045, a drug candidate designed to replace and improve on pooled human IVIG

Under the deal, Pfizer received an exclusive worldwide licence to GL-2045 for all therapeutic indications, while Gliknik received an upfront payment of $25m and is eligible for development, regulatory and commercial milestone payments

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In addition, Gliknik is eligible to receive tiered, double-digit royalties on net sales of any products that are commercialised pursuant to this licence agreement.

According to Gliknik, GL-2045 showed better results in a wide range of preclinical tests and is being developed as a potential treatment for different autoimmune diseases.

Gliknik also includes clinical compound GL-0817, which is being developed to prevent the recurrence of squamous cell cancer of the oral cavity.