Zurich-Schlieren, Switzerland, July 20, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin® therapeutics, today announced that Allergan, an AbbVie company, has informed Molecular Partners of their intent to withdraw application filings with both the European Medicines Agency (EMA) and the Japanese Regulatory Agency (PMDA) for abicipar pegol, a novel DARPin therapeutic for patients with neovascular (wet) age-related macular degeneration (nAMD).
Citing an unfavorable benefit-risk ratio, the FDA rejected Allergan and co-developer Molecular Partners’ wet AMD drug candidate Abicipar pegol.
NORTH CHICAGO, Ill., June 26, 2020 /PRNewswire/ -- Allergan, an AbbVie Company (NYSE: ABBV), and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, 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).
ZURICH (Reuters) - Swiss drugmaker Molecular Partners has suffered a setback after the U.S. Food and Drug Administration said the company’s abicipar product for a blindness-causing eye disease had an unfavorable risk-benefit profile due to inflammation.
DUBLIN, Oct. 11, 2019 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company with a more than 70-year heritage in ophthalmology and Molecular Partners (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies, today announced two-year data from the CEDAR and SEQUOIA clinical studies of investigational Abicipar in patients with neovascular (wet) age-related macular degeneration (nAMD). In the second year of these studies, four injections of Abicipar resulted in the maintenance of visual gains comparable to monthly ranibizumab. These data were presented as a late-breaking oral presentation during Retina Subspecialty Day at the Annual Meeting of the American Academy of Ophthalmology (AAO).
Allergan plc, (NYSE: AGN), a leading global pharmaceutical company and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® therapies, today announced topline safety results from MAPLE, a 28 week open-label study which enrolled 123 age-related Neovascular Macular Degeneration (nAMD) patients and evaluated the safety of abicipar produced via a modified manufacturing process. In this single arm study, treatment naïve or prior anti-VEGF treated patients received three monthly 2mg abicipar injections followed by 2mg injections every 8 weeks for up to a total of five injections through week 28.
ZURICH-SCHLIEREN, SWITZERLAND / ACCESSWIRE / October 29, 2018 / Molecular Partners AG (MOLN.SW), a clinical-stage biopharmaceutical company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announced that the phase 3 safety and efficacy data of abicipar in patients with neovascular Age-related Macular Degeneration (nAMD) were presented at the American Academy of Ophthalmology (AAO) conference in Chicago.