NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Great work tunnelvisionofplenty.

Avacincaptad pegol, (which appears to have been delayed by the company for some reason – possibly because it was not approved, although when drugs aren't approved I've often seen the NICE status updated to reflect that the drug was completely withdrawn from consideration so that may not be the case here)

NICE has postponed the appraisal of avacincaptad pegol, (also known as Izelvay in Europe) to November 2025 at the request of Astellas, likely to allow the company to gather additional data and submit a more comprehensive and robust dossier. This delay appears to be linked to the withdrawal of the MAA from the EMA in October 2024 due to concerns regarding the effectiveness of the product, as well as the FDA's issuance of a Complete Response Letter (CRL) in November 2024. Izervay was previously granted FDA approval on August 4, 2023, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

NICE

17 December 2024
Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in late November 2025. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.

https://www.nice.org.uk/guidance/awaiting-development/gid-ta11511

EMA

Astellas Pharma Europe B.V. withdrew its application for a marketing authorisation of Izelvay, a medicine intended for the treatment of geographic atrophy caused by age-related macular degeneration (AMD).
The company withdrew the application on 24 October 2024

.

The application was withdrawn after the European Medicines Agency had evaluated the information from the company and prepared questions for the company. After the Agency had assessed the company’s responses to the last round of questions, there were still some unresolved issues.

In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew the application because of the Agency’s concerns about the effectiveness of the medicine.

Active substance - avacincaptad pegol

https://www.ema.europa.eu/en/medicines/human/EPAR/izelvay#overview

FDA

The US Food and Drug Administration (FDA) has accepted the revised supplemental New Drug Application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on January 6, 2025. This revision was in response to the Agency's November 2024 Complete Response Letter (CRL).1

According to the company’s press release1, the application was refiled following a December 20, 2024, meeting between the FDA and Astellas and has been designated as a Class 1 resubmission, with a 60-day review period. This sets the target action date for February 26, 2025.

The sNDA seeks to add positive 2-year data to the IZERVAY US Prescribing Information based on results from the GATHER2 Phase 3 clinical trial.1

The company noted1 that the impact of this matter on Astellas' financial results for the fiscal year ending March 31, 2025, is expected to be minor.

IZERVAY was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD.1

https://www.ophthalmologytimes.com/view/fda-accepts-revised-supplemental-new-drug-application-for-izervay