Nezglyal deemed to have future despite latest setback

Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorization for Nezglyal (leriglitazone) following a re-examination of the filing.

Nezglyal, from privately-held drugmakers Minoryx Therapeutics and Neuraxpharm Pharmaceuticals, is a novel orally bioavailable and selective peroxisome proliferator-activated receptor (PPAR) gamma agonist that is intended for the treatment of cerebral adrenoleukodystrophy (cALD).

Minoryx and Neuraxpharm have pushed for a re-examination for conditional approval for patients with cALD, which is characterized by demyelinating brain lesions that can become rapidly progressive, leading to acute neurological decline and death after three to four years.