USFDA grants ODD status to Zydus Lifesciences medicine to treat CAPS

Zydus Lifesciences Ltd on Tuesday said the US health regulator has granted 'Orphan Drug Designation' to its 'ZYIL1' for the treatment of patients with auto-inflammatory condition cryopyrin-associated periodic syndrome (CAPS).

The grant of Orphan Drug Designation (ODD) by the US Food and Drug Administration (USFDA) for ZYIL1 provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval, the company said in a regulatory filing.

ODD is granted by the USFDA to a medicine intended to treat a condition affecting fewer than 2 lakh persons in the US, or which will not be profitable within seven years following its approval. ''This Orphan Drug Designation from the USFDA underlines the urgent need to develop ZYIL1 to address this rare and critical chronic inflammatory condition CAPS, a high unmet medical need,'' Zydus Lifesciences Ltd Chairman Pankaj R Patel said. He further said 'ZYIL1' demonstrated Phase II proof of concept in CAPS patients showing rapid clinical improvement, as early as day three which sustained till the end of the treatment, in addition to the improvement in inflammatory markers and there were no serious adverse events observed. CAPS is a rare, life-long auto-inflammatory condition and is classified under orphan disease. CAPS patients suffer from urticaria-like rash, fever, arthralgia, and increased risk of amyloidosis and also experience multiple neurological complications like sensorineural hearing loss, migraine, headache, aseptic meningitis and myalgia, the company said. In September 2022, Zydus announced positive Phase II proof-of-concept (POC) study in CAPS patients, and publication of Phase I study results in Clinical Pharmacology in Drug Development, supporting the advancement of ZYIL1 into pivotal clinical trials in cryopyrin associated periodic syndrome (CAPS) patients, it added.

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