Avacincaptad pegol

November 2024 FDA updates include approval of VARIPULSE for atrial fibrillation, removal proposal for oral phenylephrine in nasal decongestants, CRL for Ocaliva in PBC, acceptance of pz-cel gene therapy BLA for RDEB, approval of Emrosi for rosacea, acceptance of dupilumab sBLA for CSU, CRL for IZERVAY in GA, Gildeuretinol for Stargardt disease receiving Rare Pediatric and Fast Track status, approval of bimekizumab for HS, acceptance of HLX14 biosimilar BLA for denosumab, approval of Attruby for ATTR-CM, and acceptance of vutrisiran sNDA for ATTR-CM.

US FDA issues Complete Response Letter for avacincaptad pegol (IZERVAY) due to a statistical matter; Aldeyra Therapeutics' NDA for reproxalap for dry eye accepted by FDA; case report on carotid-cavernous fistula misdiagnosed as allergies; AAOpt 2024 discusses genetic testing; study links long-term blood pressure variability to visual field progression in glaucoma.

FDA issued a Complete Response Letter for Astellas Pharma's sNDA of avacincaptad pegol for geographic atrophy secondary to AMD, citing a statistical labeling issue. Astellas remains committed to addressing FDA feedback and advancing GA treatments.

The FDA issued a Complete Response Letter for Astellas Pharma's IZERVAY, citing a statistical issue in proposed labeling language. The CRL does not concern safety or efficacy. Astellas plans to collaborate with the FDA to address the feedback.

The FDA issued a Complete Response Letter to Astellas Pharma Inc. for IZERVAY, citing a statistical issue in proposed labelling language, not safety or efficacy. Astellas plans to work with the FDA to address the feedback.

Ferhina S. Ali, MD, MPH, discusses managing geographic atrophy (GA) by considering treatment timing, imaging, phase 3 trial data, and patient adherence. Ali uses an individual treatment approach, focusing on the eye with better vision in bilateral GA cases. She administers GA treatments pegcetacoplan and avacincaptad pegol every 4-6 weeks, guided by trial extension data and patient motivation. Ali emphasizes the importance of monitoring for choroidal neovascularization and progressive vision loss, and ongoing patient education.

Katherine Talcott, MD, discusses potential therapies for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) at OSN New York 2024, highlighting ANX007, Danicopan ALXN 2040, AVD-104, JNJ-1887, ASP7317, RG6501, elamipretide, Glideuretinal, AREDS/AREDS2, and ONL1204. ANX007 showed significant protection from vision loss in the ARCHER Trial, while Danicopan ALXN 2040 is an oral agent inhibiting complement factor D. AVD-104 demonstrated visual acuity gains in the SIGLEC study. Gene therapies like JNJ-1887 and ASP7317 aim to protect retinal cells. Elamipretide showed positive effects on visual function in the ReCLAIM study. Glideuretinal and AREDS/AREDS2 are antioxidants, and ONL1204 is a Fas inhibitor reducing retinal cell apoptosis.

Astellas withdraws EMA filing for avacincaptad pegol, a GA treatment, following EU regulator feedback. Despite US FDA approval as Izervay, no EU treatments exist for GA associated with AMD. Astellas remains committed to bringing the drug to market in Europe.

Astellas Pharma withdrew its marketing application for avacincaptad pegol from the EMA due to interactions, despite positive U.S. results. The company remains optimistic about the drug's clinical benefits.