AbbVie Company Allergan and Molecular Partners Receive CRL from FDA on Biologics License Application for Abicipar pegol
Allergan, an AbbVie Company (NYSE: ABBV), and Molecular Partners (OTC: MLLCF) today announced that the U.S.
Benzinga · -
Allergan, an AbbVie Company (NYSE: ABBV), and Molecular Partners (OTC: MLLCF) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin® therapy for patients with neovascular (wet) age-related macular degeneration (nAMD). The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (AMD). AbbVie plans to meet with the FDA to discuss their comments and determine next steps. "We continue to believe in the need for treatment options that provide patients with reliable vision gains and less frequent dosing for the treatment of nAMD," said Michael R. Robinson, M.D., Vice President, Global Therapeutic Area Head, Ophthalmology, AbbVie. "We are committed to working with the FDA to determine the appropriate next steps for Abicipar pegol." The global need for eye health services is projected to increase dramatically in the coming decades, posing a considerable challenge to healthcare systems. Through building a strong, active pipeline, which is focused on significant unmet needs in eye care, AbbVie is committed to