Navigating regulatory hurdles in the U.S. and Europe, plus fierce competition from rival Apellis, Astellas’ geographic ...

February is observed as American Heart Month, a period dedicated to raising awareness about heart health. The first American Heart ...

Astellas Pharma seeks Japanese conditional approval of avacincaptad pegol intravitreal solution to treat geographic atrophy: Tokyo Thursday, February 6, 2025, 09:00 Hrs [IST] Aste ...

Izervay was approved by the US Food and Drug Administration on August 4 ... Izervay is continuing to be evaluated in an open-label extension study. Astellas is a global life sciences company committed ...

Izervay (avacincaptad pegol) is a prescription injection used to treat severe age-related macular degeneration (AMD). Izervay can cause side effects that range from mild to serious. Examples ...

Amin's comments highlight that Izervay is likely on a fast track for label expansion and lifting the 1-year use restriction, which could further intensify competition in the eye drug market.

Astellas’ Izervay, meanwhile, was rejected by the FDA for a supplemental license ... was due to “a statistical matter related to labeling language proposed by Astellas.” ...

That was followed shortly after by the FDA approval of Astellas' C5 inhibitor Izervay (avacincaptad pegol), although, a subsequent attempt by the company to broaden its label was turned down.

Adding the results of EV-302 to the label makes it an option for cisplatin-eligible patients as well – a much larger population. The peak sales figure is for the drug overall, with Pfizer ...