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Eiger BioPharmaceuticals (EIGR) Reports EMA Validation of Lonafarnib MAA for Treatment of Progeria & Progeroid Laminopathies

April 27, 2020 8:08 AM

Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) today announced that the European Medicines Agency (EMA) has completed its validation of the Marketing Authorization Application (MAA) for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies. Validation of the MAA confirms that the submission is accepted and starts the formal review process by the EMA's Committee for Human Medicinal Products (CHMP). The EMA previously granted an accelerated assessment of the MAA.

Lonafarnib is a well‐characterized, first-in-class, oral inhibitor of farnesyltransferase. A study published in JAMA 2018 demonstrated an 88% reduction in the risk of mortality in patients with Progeria treated with lonafarnib monotherapy. The most commonly reported adverse events are gastrointestinal in nature. Many patients with Progeria have received continuous lonafarnib therapy for greater than 10 years. There is currently no approved therapy for Progeria or Progeroid Laminopathies.

"Validation of the MAA combined with accelerated assessment from the EMA represents another major step toward the anticipated approval of lonafarnib in Progeria and Progeroid Laminopathies," said David Cory, President and CEO of Eiger. "We look forward to working with the Progeria community, including The Progeria Research Foundation (PRF) and Progeria Family Circle (PFC), to bring the first approved treatment to children and young adults with Progeria and Progeroid Laminopathies."

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