Astellas pulls geographic atrophy drug filing in the EU

Astellas confirmed today that it will withdraw its EMA filing for avacincaptad pegol as a treatment for eye disorder geographic atrophy (GA), based on feedback from the EU regulator.

It is a major setback for a programme that lay at the heart of Astellas' $5.9 billion acquisition of the drug's developer Iveric Bio last year.

In a statement, Astellas said the move follows interactions with the EMA's human medicines committee, the CHMP, adding that it remains "fully committed" to eventually bringing avacincaptad pegol to market in Europe.

It is a different story for the company in the US, where the complement C5 inhibitor was approved by the FDA as Izervay last year for GA secondary to age-related macular degeneration (AMD), a leading form of blindness. That approval set up a market clash with Apellis Pharma's complement C3 inhibitor Syfovre (pegcetacoplan), which was cleared a few months earlier.

There are currently no approved treatments outside of the US for GA associated with AMD, according to Astellas. Avacincaptad pegol was scheduled to be reviewed at the CHMP's October meeting, but was left off the agenda.

The CHMP's reservations about the drug have not been made public, but Astellas said in its statement on the withdrawal that it "maintains that the clinically meaningful benefit of ACP in slowing GA lesion growth outweighs the risks."

In both the GATHER 1 and 2 trials, avacincaptad pegol given as an injection into the eye slowed disease progression by up to 35% over 12 months compared to a sham control, which the drugmaker claims differentiates it from Syfovre.

"GA is a devastating progressive disease, which leads to severe and irreversible visual impairment and blindness," said Marci English, Astellas head of biopharma and ophthalmology development.

"While we are disappointed with the CHMP's response, we have seen the impact this medicine has had for GA patients in the US and remain committed to serving unmet patient needs globally," she added.

The drugmaker said it is reviewing the potential financial impact of the decision for the fiscal year ending 31st March 2025.

Izervay and Syfovre are addressing a potentially enormous market, leading analysts to previously predict blockbuster sales levels for both drugs, although, Apellis' drug has been linked to side effects that have trimmed back some forecasts. So far, Astellas has not indicated what it may do to pursue the refiling of its drug in Europe.

GA affects an estimated 1.5 million people in the US, but approximately three-quarters of people living with the condition are thought to be undiagnosed. Without treatment, an estimated 66% of people with GA may become blind or severely visually impaired.

Photo by Crazy Cake on Unsplash