FDA changes its mind on Astellas' geographic atrophy drug
Astellas has shored up the competitive profile of Izervay as a treatment for eye disorder geographic atrophy (GA), getting FDA approval for an extended treatment duration.
The US regulator turned down Astellas' marketing application for the new Izervay (avacincaptad pegol) labelling last November due to a "statistical matter related to labelling language" that has now been resolved.
The new wording removes a one-year limit on the duration of treatment with the complement C5 inhibitor for GA secondary to age-related macular degeneration (AMD) – a leading cause of blindness – doing away with a restriction that has been seen as holding back its use and benefitting rival therapy Syfovre (pegcetacoplan) from Apellis.
Marci English, head of biopharma and ophthalmology development at Astellas Pharma, said the FDA's change of heart will "further [solidify] Izervay's status as a trusted choice for thousands of GA patients since its launch in 2023."
The new labelling is based on the results of the phase 3 GATHER2 trial, which showed that GA patients could get a benefit from the drug with dosing every other month, and also that there were benefits to continuing treatment out to two years.
The less frequent dosing frequency has not been included in the updated prescribing information, however. Complement C3 inhibitor Syfovre is already approved with dosing frequency of between 25 and 60 days, based on clinical trial data that also showed a benefit over two years.
The new approval is, nevertheless, good news for Astellas, which acquired Izervay as part of its $5.9 billion acquisition of the drug's developer, Iveric Bio, in 2023. Efforts to bring the drug to market elsewhere have run into trouble, however, and Astellas withdrew a marketing application for Izervay in the EU last October after getting feedback on its application from the EMA.
It was filed for approval in Japan earlier this month, and Astellas is considering submitting Izervay in selected EU markets, rather than going down the EU-wide regulatory route.
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 of the more optimistic forecasts.
Astellas reported sales of Izervay rocketed to JPY 44.4 billion (around $289 million) in the first nine months of its current fiscal year – a near-ninefold increase on the same year-earlier period – although it still recorded a charge of JPY 115 billion linked to delays for the programme in ex-US markets.
For comparison, Apellis recorded Syfovre sales of around $445 million in the first nine months of calendar 2024, with recent turnover showing signs of plateauing.
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.
Image by Jason Gillman from Pixabay
